ONTARGET Primary objectives: To determine if (a) Telmisartan (Micardis) 80 mg daily and Ramipril (Delix protect) 10 mg daily combination therapy is more effective in reducing the composite endpoint of CV death, MI, stroke or hospitalization for CHF compared with Ramipril 10 mg alone; and (b) Telmisartan 80 mg daily is at least as effective as (i.e. not less effective than) Ramipril 10 mg daily, on this endpoint.

TRANSCEND This parallel trial is to determine in ACE-I-intolerant patients if telmisartan 80 mg daily is superior to placebo in reducing the composite endpoint of cardiovascular death, MI, stroke or hospitalization for CHF.

Condition	Intervention	Phase
Cardiovascular Diseases	Drug: Combination of Telmisartan and Ramipril  Drug: Ramipril  Drug: Telmisartan	Phase IV

Further Study Details: 

Primary Outcomes: 1. Cardiovascular death 2. Non-fatal myocardial infarction 3. Non-fatal stroke 4. Hospitalization for congestive heart failure
Secondary Outcomes: 1. Newly diagnosed congestive heart failure 2. Cardiovascular revascularization procedures 3. Newly diagnosed diabetes 4. Cognitive decline (adjudication will be done by a special committee) 5. New onset of atrial fibrillation 6. Nephropathy
Expected Total Enrollment:  31546

ONTARGET: After a three-week (+ 1 week) single-blind run-in period using both ramipril and telmisartan, to assess patient tolerability and compliance to study medications, patients will be randomized to one of the three double-blind treatment arms: telmisartan 80 mg plus ramipril placebo, ramipril 5 mg plus telmisartan placebo, or the combination of telmisartan 80 mg + ramipril 5 mg. After an initial two weeks of randomized treatment, ramipril will be titrated from 5 mg to 10 mg in both the ramipril monotherapy and the combination arms.

TRANSCEND: Patients with a known history of ACE-inhibitor intolerance will undergo a three-week (+ 1 week) single-blind run-in starting with placebo to match telmisartan 80mg for one week followed by two weeks of telmisartan 80mg. Patients will be randomized to receive either telmisartan 80mg or matching placebo.

Double-blind study medications are to be taken once daily in the morning for as long as the patient is in the trial (from a minimum of 3.5 years to a maximum of 5.5 years). Patients will return 6 weeks (+1 week) after randomization for the first follow-up visit. The next visit will be scheduled at 6 months (+ 4 weeks) after randomization. Thereafter, visits will be scheduled at six-monthly (+ 4 weeks) intervals. Clinical study outcomes, other clinical events and expected serious adverse events will be documented at each visit. Any unexpected serious associated adverse event, which is not a study outcome, will be reported to the CCC Project Office immediately. Any patient who stops taking study medication(s) during the randomized period will remain in the study for observation at the scheduled visits, until the end of the study.

Study Hypothesis:

ONTARGET The main study is expected to achieve two goals: (1) to show that the combination of telmisartan (Micardis) 80 mg plus ramipril (Delix protect) 10 mg is superior to ramipril 10 mg, and (2) to show that telmisartan 80 mg is at least as good as (i.e. not inferior to) ramipril 10 mg. These goals are formulated in terms of hazard ratios, which will be calculated, based on the times to the first occurrence of one of the components of the 4-fold primary endpoint.

The non-inferiority margin delta is chosen to be 1.13. This choice guarantees that telmisartan preserves more than 50% of the ramipril effect vs. placebo if proven to be not inferior to ramipril.

As can be seen from the formulation of the superiority and non-inferiority hypotheses, both are one-sided. The level of significance planned for each comparison is 2.5%.

No adjustment for testing the two pairs of hypotheses is foreseen. The type-I error rate for the two hypotheses is the same whether they are tested in the framework of a single 3-arm design, as in this study, or in the framework of two independent 2-arm studies. In the latter case no adjustment is foreseen.

TRANSCEND

The goal of TRANSCEND is to show that telmisartan 80 mg is superior to placebo in patients intolerant to ACE inhibitors. The statistical expression of this goal is in terms of the hazard ratio for telmisartan vs. placebo:

As in the main study, the formulation of the hypotheses is one-sided. The level of significance planned for this comparison, which is regarded as a study on its own, is 2.5%.

Comparison(s):

ONTARGET:

Telmisartan vs. Ramipril vs. Telmisartan + Ramipril

TRANSCEND:

Telmisartan vs. Placebo

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

Criteria

Coronary Artery Disease: Previous MI (> 2 days prior to informed consent), or stable or previous unstable angina (> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel PTCA (> 30 days prior to informed consent), or previous multivessel CABG without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.

Other High Risk:

1. Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm BP ratio < 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing;
2. Previous stroke;
3. TIA > 7 days and < 1 year prior to informed consent;
4. Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, LVH, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease.

No definite and specific indication or contraindication for any of the study treatments.

Written informed consent.

Alabama
      Boehringer Ingelheim Investigational Site, Athens,  Alabama,  35611,  United States
      Boehringer Ingelheim Investigational Site, Birmingham,  Alabama,  35294-0012,  United States
Arizona
      VAMC Phoenix - Medical Service (111), Phoenix,  Arizona,  85012,  United States
      Saquaro Clinical Research, Tucson,  Arizona,  85712,  United States
      Tuscon V.A. Medical Center, TUSCON,  Arizona,  85723,  United States
      Marcopia Medical Center, Phoenix,  Arizona,  85008,  United States
Arkansas
      Boehringer Ingelheim Investigational Site, Bentonville,  Arkansas,  72712,  United States
California
      UCLA Division of CArdiology, Los Angeles,  California,  90095,  United States
      University of California Davis Medical Center, Sacramento,  California,  95814,  United States
      East Bay Clinical Trials, Concord,  California,  94520,  United States
      San Leandro,  California,  94578,  United States
      Naval Medical Center, San Diego,  California,  92134-1201,  United States
      Kaiser Permanente, Los Angeles,  California,  90027,  United States
      Kaiser Permanente, Harbor City,  California,  90710,  United States
      Olive View Education and Research Center, Sylmar,  California,  91342,  United States
      Boehringer Ingelheim Investigational Site, West Hills,  California,  91307,  United States
      Loma Linda VA Medical Center, Loma Linda,  California,  92354,  United States
Connecticut
      Boehringer Ingelheim Investigational Site, Bridgeport,  Connecticut,  06606,  United States
      University of Connectict Health Services Center, Farmington,  Connecticut,  06030-3212,  United States
District of Columbia
      Boehringer Ingelheim Investigational Site, Washington,  District of Columbia,  20060,  United States
Florida
      Medical Research Institute, Tampa,  Florida,  33607,  United States
      Cleveland Clinic Florida, Weston,  Florida,  33331,  United States
      Panama City,  Florida,  32401,  United States
      Boehringer Ingelheim Investigational Site, Palm Harbor,  Florida,  34684,  United States
      Shands Teaching Hospital @ Univ. of FL, Gainesville,  Florida,  32610,  United States
      Treasure Coast Infectious Disease Consultants (TCIDC), Vero Beach,  Florida,  32960,  United States
Georgia
      Kaiser Permanente of Georgia, Tucker,  Georgia,  30084,  United States
      Conyers,  Georgia,  30094,  United States
      Val-Oak Professional Corporation, Valdosta,  Georgia,  31602,  United States
      Southern Clinical Research and Management, Inc., Augusta,  Georgia,  30904,  United States
      VAMC Augusta, Augusta,  Georgia,  30904-6285,  United States
      St. Joseph''''s Candler Health System, Savannah,  Georgia,  31405,  United States
      1429 Harper St., Augusta,  Georgia,  30912,  United States
      Primary Care Center, Sandersville,  Georgia,  31082,  United States
Idaho
      Idaho State University, Pocatello,  Idaho,  83209-8357,  United States
Illinois
      Cook County Hospital, Chicago,  Illinois,  60612,  United States
      Cardiology - Internal Medicine Associates, SC, Oak Lawn,  Illinois,  60453,  United States
      Suburban Heights Medical Center, SC, Chicago Heights,  Illinois,  60411-1790,  United States
Iowa
      Iowa Heart Clinic, Des Moines,  Iowa,  50314,  United States
Louisiana
      Medicine II Clinic, Monroe,  Louisiana,  71201,  United States
      Cardiac Centers of Louisiana, Shreveport,  Louisiana,  71103-3971,  United States
Maryland
      Boehringer Ingelheim Investigational Site, Baltimore,  Maryland,  21204,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Minnesota
      Minneapolis VAMC (111C1), Minneapolis,  Minnesota,  55417,  United States
      Berman Center for Outcomes and Clinical Research, Minneapolis,  Minnesota,  55404,  United States
      Regions Hospital, St. Paul,  Minnesota,  55101,  United States
Mississippi
      Mid Delta Family Practice Clinic, Cleveland,  Mississippi,  38732,  United States
      Phillips Medical Services, Jackson,  Mississippi,  39209,  United States
      VA Gulf Coast Veterans Health Care Systems, Biloxi,  Mississippi,  39531-2410,  United States
Missouri
      Kansas City,  Missouri,  64128,  United States
      VAMC St. Louis, St. Louis,  Missouri,  63106,  United States
      People''''s Health Centers, St. Louis,  Missouri,  63112,  United States
Nebraska
      Cardiac Center in Omaha, NE, Omaha,  Nebraska,  68131-2044,  United States
Nevada
      VAMC Las Vegas, Las Vegas,  Nevada,  89106,  United States
New Jersey
      Department of Medicine, Camden,  New Jersey,  08103,  United States
      Westwood Cardiology Associates, Westwood,  New Jersey,  07675,  United States
      UMDNJ - New Jersey Medical School, Newark,  New Jersey,  07103,  United States
      Veteran''''s Affairs New Jersey Health Care System, East Orange,  New Jersey,  07018,  United States
New York
      Great Lakes Medical Research, Westfield,  New York,  14787,  United States
      SUNY Downstate, Brooklyn,  New York,  11203,  United States
      Rochester,  New York,  14618,  United States
      Boehringer Ingelheim Investigational Site, Bronx,  New York,  10467,  United States
      Rochester Cardiopulmonary Group, Rochester,  New York,  14621,  United States
      Boehringer Ingelheim Investigational Site, Williamsville,  New York,  14221,  United States
      Kaleida Health, Buffalo,  New York,  14203,  United States
      Boehringer Ingelheim Investigational Site, Northport,  New York,  11768,  United States
      Lawrence Higgins, M.D., New York,  New York,  10011,  United States
      Boehringer Ingelheim Investigational Site, Scarsdale,  New York,  10583,  United States
      Cornell Internal Medical Associates, New York,  New York,  10021,  United States
      Boehringer Ingelheim Investigational Site, New York,  New York,  10034,  United States
      Boehringer Ingelheim Investigational Site, Kingston,  New York,  12401,  United States
North Carolina
      Boehringer Ingelheim Investigational Site, Durham,  North Carolina,  27710,  United States
      Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157,  United States
North Dakota
      VAMC Fargo, Fargo,  North Dakota,  58102,  United States
Ohio
      Mansfield,  Ohio,  44903,  United States
      Cincinnati,  Ohio,  45219,  United States
      Oklahoma Foundation for Cardiovascular Research, Oklahoma City,  Ohio,  73104,  United States
      VAMC Dayton, Dayton,  Ohio,  45428,  United States
      Boehringer Ingelheim Investigational Site, Cleveland,  Ohio,  44195,  United States
Oklahoma
      attn: Rae Wheeler, Oklahoma City,  Oklahoma,  73112,  United States
      University of Oklahoma College of Medicine - Tulsa, Tulsa,  Oklahoma,  74129,  United States
      Ringrose Clinic, Inc., Guthrie,  Oklahoma,  73044,  United States
Oregon
      Portland Cardiovascular Institute, Portland,  Oregon,  97216,  United States
Pennsylvania
      Osteopathic Internal Medicine Associates, Erie,  Pennsylvania,  16508,  United States
      Cardiology Consultants of Philadelphia, Philadelphia,  Pennsylvania,  19148,  United States
      Buxmont Cardiology Association, Sellersville,  Pennsylvania,  18960,  United States
South Carolina
      VAMC Charleston, Charleston,  South Carolina,  29401,  United States
      USC Specialty Clinics, Columbia,  South Carolina,  29203,  United States
Texas
      Research Institute of Dallas, Dallas,  Texas,  75231,  United States
      Dallas,  Texas,  75235,  United States
      Clinical Cardiology Research Center, Dallas,  Texas,  75246,  United States
      Frood Eelani DO - Internal Medicine, Fort Worth,  Texas,  76104,  United States
      Houston,  Texas,  77030-4298,  United States
      VAMC Houston, Houston,  Texas,  77030,  United States
      Dallas VAMC, Dallas,  Texas,  75216,  United States
      Smith Tower, Houston,  Texas,  77030,  United States
Virginia
      Clinical Research Institute of Northern Virginia, Burke,  Virginia,  22015,  United States
Washington
      Harborview Medical Center, Seattle,  Washington,  98104,  United States
Wisconsin
      Milwaukee,  Wisconsin,  53295,  United States
Argentina
      Boehringer Ingelheim Investigational Site, Rosario,  Argentina
Australia, Australian Capital Territory
      The Canberra Hospital, Woden,  Australian Capital Territory,  2606,  Australia
Australia, New South Wales
      Coffs Harbour Cardiovascular Clinic, Coffs Harbour,  New South Wales,  2450,  Australia
      Central Coast Neuroscience Research, Gosford,  New South Wales,  2250,  Australia
      John Hunter Hospital, Newcastle,  New South Wales,  2305,  Australia
      Royal North Shore Hospital, St. Leonards,  New South Wales,  2065,  Australia
      Concord Repatriation General Hospital, Concord,  New South Wales,  2139,  Australia
      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia
      The Prince of Wales Hospital, Randwick,  New South Wales,  2031,  Australia
      St George Private Hospital, Kogarah,  New South Wales,  2217,  Australia
      St. George Hospital, Kogarah,  New South Wales,  2217,  Australia
      Royal Prince Alfred Hospital, Camperdown,  New South Wales,  2005,  Australia
      Woolongong Hospital, Wollongong,  New South Wales,  2500,  Australia
      Gosford Hospital, Gosford,  New South Wales,  2250,  Australia
      Boehringer Ingelheim Investigational Site, Kogarah,  New South Wales,  2217,  Australia
Australia, Queensland
      The Prince Charles Hospital, Chermside,  Queensland,  4032,  Australia
      Peninsula Clinical Research Centre, Kippa-Ring,  Queensland,  4021,  Australia
      Royal Brisbane Hospital, HERSTON,  Queensland,  4029,  Australia
      Gold Coast Hospital, Southport,  Queensland,  4215,  Australia
      Princess Alexandra Hospital, Woolloongabba,  Queensland,  4102,  Australia
Australia, South Australia
      Flinders Medical Centre, Bedford Park,  South Australia,  5042,  Australia
      Port Lincoln "The Investigator" Clinic, Port Lincoln,  South Australia,  5606,  Australia
      Repatriation General Hospital, Daw Park,  South Australia,  5043,  Australia
      Repatriation General Hospital, Daw Park,  South Australia,  5043,  Australia
Australia, Tasmania
      Launceston General Hospital, Launceston,  Tasmania,  7250,  Australia
Australia, Victoria
      The Geelong Hospital, Geelong,  Victoria,  3220,  Australia
      Royal Melbourne Hospital, Parkville,  Victoria,  3050,  Australia
      Austin & Repatriation Medical Centre, West Heidelberg,  Victoria,  3081,  Australia
      Box Hill Hospital, Box Hill,  Victoria,  3128,  Australia
      The Alfred Hospital, Prahran,  Victoria,  3181,  Australia
      Baker Medical Research Centre, Prahran,  Victoria,  3181,  Australia
      The Northern Hospital, Epping,  Victoria,  3076,  Australia
      St. Vincents Hospital, Fitzroy,  Victoria,  3065,  Australia
      Maroondah Hospital, Ringwood East,  Victoria,  3135,  Australia
Australia, Western Australia
      Sir Charles Gairdner Hospital, Nedlands,  Western Australia,  6009,  Australia
      Royal Perth Hospital, Perth,  Western Australia,  6100,  Australia
      Fremantle Hospital, Fremantle,  Western Australia,  6160,  Australia
Austria, A
      A.ö.Krankenhaus d. Barmherzigen Schwestern Wels, Wels,  A,  4600,  Austria
      Univ.-Klinik für Innere Medizin II, Wien,  A,  1090,  Austria
      Hanusch Krankenhaus, Wien,  A,  1140,  Austria
      Landeskrankenhaus Graz West, Graz,  A,  8020,  Austria
      Krankenhaus St. Elisabeth Wien, Wien,  A,  1030,  Austria
Belgium
      Virga Jesseziekenhuis, Hasselt,  3500,  Belgium
      ZOL Campus Sint-Jan, Genk,  3600,  Belgium
      Centre Hospitalier du Bois de l''''Abbaye et de Hesbaye, Seraing,  4100,  Belgium
      Cliniques Universitaires U.C.L., Godinne,  5530,  Belgium
      C.H.U. de Tivoli, Haine-Saint-Paul,  7100,  Belgium
      UZ Gasthuisberg, Leuven,  3000,  Belgium
      Onze-Lieve-Vrouwziekenhuis, Aalst,  9300,  Belgium
      Maria Ziekenhuis N.-L. Campus Neerpelt, Neerpelt,  3910,  Belgium
      Sint-Elisabethziekenhuis, TURNHOUT,  2300,  Belgium
      AZ Sint-Maarten Campus Mechelen, Mechelen,  2800,  Belgium
      A.Z. Klina, Brasschaat,  2930,  Belgium
      Cliniques Universitaires Saint-Luc, Woluwé-Saint-Lambert,  1200,  Belgium
      C.H.U. de Charleroi - Site de Charleroi, Charleroi,  6000,  Belgium
      H.U. Erasme, Anderlecht,  1070,  Belgium
      Algemeen Ziekenhuis St.-Jozef, TURNHOUT,  2300,  Belgium
      C.H. Jolimont - Lobbes, Haine-Saint-Paul,  7100,  Belgium
      Sint-Jozefkliniek, Bornem,  2880,  Belgium
      A.Z. Sint-Jan, Brugge,  8000,  Belgium
      Heilig Hartziekenhuis, Roeselare,  8800,  Belgium
      Algemeen Centrumziekenhuis Antwerpen/Stuivenberg, Antwerpen,  2060,  Belgium
      Heilig Hart van Jezuskliniek, Mol,  2400,  Belgium
Canada
      Levis,  G6V 4Z5,  Canada
      Portage Clinical Studies, Manitoba,  R1N 3V5,  Canada
      Quebec,  G1J 1Z6,  Canada
      Hop. Du St. Sacrement, Quebec,  G1S 4L8,  Canada
Canada, Alberta
      C849 Division of Cardiology, Foothills Medical Centre, Calgary,  Alberta,  T2N 2T9,  Canada
      Cardiology Consultants - Heart Health Institute, Calgary,  Alberta,  T2E 7C5,  Canada
      CHA/University Hospital, Edmonton,  Alberta,  T6G 2S2,  Canada
Canada, British Columbia
      Kelowna,  British Columbia,  V1Y 1T2,  Canada
      Penticton Regional Hospital, Penticton,  British Columbia,  V2A 3G6,  Canada
      Apex Clinical Research Inc., Victoria,  British Columbia,  V8V 3N7,  Canada
      Respiratory Clinic, Vancouver,  British Columbia,  V5Z 3J5,  Canada
      New West Cardiac Research, New Westminster,  British Columbia,  V3L 3W4,  Canada
      Gain Medical Centre, Coquitlam,  British Columbia,  V3K 3P4,  Canada
      Boehringer Ingelheim Investigational Site, Campbell River,  British Columbia,  v9W 5Y4,  Canada
      North Vancouver,  British Columbia,  V7L 2P7,  Canada
Canada, Manitoba
      St. Pierre,  Manitoba,  R0A 1V0,  Canada
Canada, Newfoundland and Labrador
      James Paton Memorial Hospital, Gander,  Newfoundland and Labrador,  A1V 1P7,  Canada
      The General Hospital, St. John''''s,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Nova Scotia
      Division of Respirology, Halifax,  Nova Scotia,  B3H 3A7,  Canada
      Antigonish Clinical Trials, Antigonish,  Nova Scotia,  B2G 2C2,  Canada
Canada, Ontario
      Etobicok Cardiology, Rexdale,  Ontario,  M9V 4B8,  Canada
      Sunnybrook & Women''''s College Health Sciences Centre, Toronto,  Ontario,  M4N 3M5,  Canada
      West Cardiology Research, New Westminster,  Ontario,  V3L 3W4,  Canada
      565 Sanatorium Road, Hamilton,  Ontario,  L9C 7N4,  Canada
      1053 Carling Avenue, Ottawa,  Ontario,  K1Y 4E9,  Canada
      Newmarket,  Ontario,  L3Y 8V3,  Canada
      Oshawa,  Ontario,  L1H 1C5,  Canada
      HGH McMaster Clinic, Hamilton,  Ontario,  L8L 2X2,  Canada
      Neureka Research Corporation -- Willet Green Miller Centre, Sudbury,  Ontario,  P3E 6B4,  Canada
      205-700 Tecumseh Road E, Windsor,  Ontario,  N8X 4T2,  Canada
      St. Joseph''''s Hospital Cardiac Research, Hamilton,  Ontario,  L8P 3B6,  Canada
      Group Health Centre, Sault Ste. Marie,  Ontario,  P6B 1Y5,  Canada
      London HSC - University Hospital, London,  Ontario,  N6A 5A5,  Canada
      Vexler Health Services, Ottawa,  Ontario,  K2A 3Z3,  Canada
      Boehringer Ingelheim Investigational Site, Willowdale,  Ontario,  M2K 2W2,  Canada
      Orleans Medical-Dental Centre, Orleans,  Ontario,  K1C 1S6,  Canada
      Niagara Falls Medical Centre, Niagara Falls,  Ontario,  L2E 7H1,  Canada
      Scarborough Cardiology Research, Scarborough,  Ontario,  M1E 5E9,  Canada
      Medical Sciences Building, Oshawa,  Ontario,  L1J 2J9,  Canada
      CLIKS Medical Research Corp, Thunder Bay,  Ontario,  P7B 2Z3,  Canada
      Boehringer Ingelheim Investigational Site, Hamilton,  Ontario,  L8M 1K7,  Canada
      Boehringer Ingelheim Investigational Site, Mississauga,  Ontario,  L5B 2P7,  Canada
      St. Michael''''s Hospital, Toronto,  Ontario,  M5B 1W8,  Canada
      HGH McMaster Clinic, Hamilton,  Ontario,  L8L 2X2,  Canada
      HGH McMaster Clinic, Hamilton,  Ontario,  L8L 2X2,  Canada
Canada, Quebec
      Recherche Invascor, Longueuil,  Quebec,  J4N 1E1,  Canada
      Hopital Laval - Institute Cardiologie de Quebec, Ste Foy,  Quebec,  G1V 4G5,  Canada
      Boehringer Ingelheim Investigational Site, Longueuil,  Quebec,  J4N 1N6,  Canada
      C/O Peter Carmichael, Longueuil,  Quebec,  J4N 1L6,  Canada
      Boehringer Ingelheim Investigational Site, Longueuil,  Quebec,  J4N 1N6,  Canada
      Montreal Heart Institute, Montreal,  Quebec,  H1T 1C8,  Canada
      Medi - recherche Inc., Montreal,  Quebec,  H3P 3H5,  Canada
      CHUM - Hotel Dieu, Montreal,  Quebec,  H2W 1T8,  Canada
      Pavillon Rachel Tourigny, Montreal,  Quebec,  H1T 2M4,  Canada
      Centre hospitalier Pierre-Le Gardeur, Terrebonne,  Quebec,  J6V 2H2,  Canada
      Ctr Hospitalier Beauce Etchemin, St George de Beauce,  Quebec,  G5Y 4T8,  Canada
      Centre De Recherche Clinique, Laval,  Quebec,  H7T 2P5,  Canada
      Boehringer Ingelheim Investigational Site, Longueuil,  Quebec,  J4N 1N6,  Canada
      Boehringer Ingelheim Investigational Site, Longueuil,  Quebec,  J4N 1N6,  Canada
      Longueuil,  Quebec,  J4N 1N6,  Canada
      Centre Hospitalier de Vallees de l''''Outaouais Gatineau, Gatineau,  Quebec,  J8P 7H2,  Canada
Canada, Saskatchewan
      701 Avenue P North, Saskatoon,  Saskatchewan,  S7L 2W1,  Canada
      Specialists - Internal Medicine, Saskatoon,  Saskatchewan,  S7K 0H6,  Canada
      SDRI - University of Saskatchewan, Saskatoon,  Saskatchewan,  S7N 3R2,  Canada
      SDRI - University of Saskatchewan, Saskatoon,  Saskatchewan,  S7N 3R2,  Canada
      SDRI - University of Saskatchewan, Saskatoon,  Saskatchewan,  S7N 3R2,  Canada
      SDRI - University of Saskatchewan, Saskatoon,  Saskatchewan,  S7N 3R2,  Canada
China
      People''''s Hospital of Beijing University, China,  China
      Chaoyang Hospital Heart Centre, China,  China
      An Zhen Hospital of Beijing Second Medical University, China,  China
      Beijing Clinical Research Center, Dept of Medicine, China,  China
      Beijing Hypertension League Institute, China,  China
      General Hospital of Navy, PLA, China,  China
      Beijing Military Areas, Beijing,  100700,  China
      Neurology Department, Hubei Province,  China
      No. 155 Nanjingbeijie Street, Shen Yang,  China
      QingDao,  China
      Weizikeng,  China
      Tianjin,  China
      Department of Cardiovascular, ShanDong Province,  China
      Clinical Trial Department, ShanDong Province,  China
      HeBei Province,  China
Czech Republic
      University Hospital Motol, Prague 5,  150 06,  Czech Republic
      Faculty Hospital of St. Anna, Brno,  656 91,  Czech Republic
      Faculty Hospital of St. Anna, Brno,  656 91,  Czech Republic
      Hospital Kladno, Kladno,  27259,  Czech Republic
      Hospital Pribram, Pribram 1,  26126,  Czech Republic
      Faculty Hospital Kralovske Vihohrady, Prague 10,  100 35,  Czech Republic
      Hospital Usti nad Orlici, Usti nad Orlici,  562 18,  Czech Republic
      Klaudian''''s Hospital, Mlada Boleslav,  29301,  Czech Republic
      Havirov Hospital, Havirov,  73601,  Czech Republic
      Plzen Hospital, Plzen,  30446,  Czech Republic
      General University Hospital, Praha-2,  128 08,  Czech Republic
Denmark
      Lunge-allergi ambulatorium, Holbæk,  DK-4300,  Denmark
      Speciallæge Klinik, Frederiksberg C,  DK-1900,  Denmark
      Medicinsk afdeling B3, Slagelse,  DK-4200,  Denmark
      Frederiksberg Hospital, Frederiksberg,  DK-2000,  Denmark
      Sygehus Fyn Svendborg, Svendborg,  DK-5700,  Denmark
      Kardiologisk afd. A, Aarhus C,  DK-8000,  Denmark
      Aalborg Sygehus Syd, Aalborg,  DK-9000,  Denmark
      Medical Dept. B0642, Hillerød,  DK-3400,  Denmark
      Dept. of Cardiology, 110, Hvidovre,  DK-2650,  Denmark
      Medicinsk Afdeling, D8D, Randers,  DK-8900,  Denmark
      Helsingør Sygehus, Helsingør,  DK-3000,  Denmark
      Medical Departmnet 2051, Skive,  DK-7800,  Denmark
Finland
      Tutkimusyksikkö, Oulun kaupunki,  FI-90015,  Finland
      Tikkurilan sosiaali- ja terveyskeskus, Vantaa,  FI-01300,  Finland
      Jyväskylän terveystalo, Jyväskylä,  FI-40100,  Finland
      Kansanterveyslaitos, Helsinki,  FI-00300,  Finland
      Hämeenlinnan lääkärikeskus, Hämeenlinna,  FI-13100,  Finland
      Liperin terveyskeskus, Liperi,  FI-83100,  Finland
      Kuusankosken terveyskeskus, Kuusankoski,  FI-45700,  Finland
      Turun yliopistollinen keskussairaala, Sisätautien klinikka, Turku,  FI-20520,  Finland
      Kuopion yliopisto, Kansanterv.tiet. ja yleislääket. laitos, Kuopio,  FI-70211,  Finland
      Helsingin Lääkärikeskus, Helsinki,  FI-00100,  Finland
France
      Boehringer Ingelheim Investigational Site, Rennes,  France
      Cabinet Médical, Gemenos,  13420,  France
      Beziers,  France
      Broglie,  France
      Saint-Pierre-de-Chandieu,  France
      Albens,  France
      Hyeres,  France
      Ortez,  France
      La Rochelle,  France
      Castelnaudary,  France
      Egletons,  France
      Husseren Wesserlin,  France
      Boehringer Ingelheim Investigational Site, Nantes,  44300,  France
      Boehringer Ingelheim Investigational Site, Tours,  France
      Boehringer Ingelheim Investigational Site, Bourges,  France
      Boehringer Ingelheim Investigational Site, Saint Martin dHyeres,  France
      Boehringer Ingelheim Investigational Site, Saint-Romain-sur-Cher,  France
      Boehringer Ingelheim Investigational Site, L''''Aigle,  France
      Boehringer Ingelheim Investigational Site, Paris,  France
      Boehringer Ingelheim Investigational Site, Niort,  France
      Boehringer Ingelheim Investigational Site, Le Pradet,  France
      Boehringer Ingelheim Investigational Site, Erigne,  France
      Boehringer Ingelheim Investigational Site, Saint-Julien-des-Landes,  France
      Boehringer Ingelheim Investigational Site, Nantes,  France
      Boehringer Ingelheim Investigational Site, Strasbourg,  France
Germany
      Charité, Campus Virchcow-Klinikum, Berlin,  13353,  Germany
      Fachärztin für Innere Medizin, Künzing,  94550,  Germany
      Facharzt für Allgemeinmedizin, Haag,  83527,  Germany
      Kardiologin, Heidelberg,  69120,  Germany
      Praxis Dres. Med. Vollgraf / Hahn, Dortmund,  44263,  Germany
      Kreiskrankenhaus Böblingen, Böblingen,  71032,  Germany
      Kreiskrankenhaus Starnberg GmbH, Starnberg,  82319,  Germany
      Arzt für Innere Medizin, Kelkheim,  65779,  Germany
Germany, -
      Evangelisches Krankenhaus, WITTEN,  -,  58455,  Germany
      Schwalm-Eder-Kliniken GmbH, Melsungen,  -,  34212,  Germany
      Diabetes Klinik Bad Mergentheim, Bad Mergentheim,  -,  97980,  Germany
      Institut für klinische Forschung Sehnert IKFS, Dortmund,  -,  44139,  Germany
      Deutsche Klinik für Diagnostik GmbH, Wiesbaden,  -,  65191,  Germany
      Universitätsklinik des Saarlandes, HOMBURG / SAAR,  -,  66421,  Germany
      Städisches Krankenhaus Süd, LÜBECK,  -,  23560,  Germany
      Universtitätskliniken Mainz, Mainz,  -,  55101,  Germany
      Klinikum Köln-Merheim, Köln,  -,  51109,  Germany
      Internist, ESSEN,  -,  45136,  Germany
      KFH Dialysezentrum, Eberswalde,  -,  16225,  Germany
      Klinikum Karlsburg, Karlsburg,  -,  17495,  Germany
      Universitätsmedizin Berlin, Berlin,  -,  10112,  Germany
      Charité Campus Buch, Berlin,  -,  13125,  Germany
      Universität Erlangen-Nürnberg, Nürnberg,  -,  90471,  Germany
      Robert-Bosch-Krankenhaus, Stuttgart,  -,  70376,  Germany
      KfH Dialysezentrum, München,  -,  80804,  Germany
      Universitätsklinikum Eppendorf, Hamburg,  -,  20246,  Germany
      Diabeteszentrum Bad Lauterberg, Bad Lauterberg,  -,  37431,  Germany
      Curschmann Klinik, Timmendorfer Strand,  -,  23669,  Germany
      Innere Abteilung, Offenbach am Main,  -,  63071,  Germany
      Krankenanstalten Gilead GmbH, Bielefeld,  -,  33617,  Germany
      Kardiologe, Dresden,  -,  01099,  Germany
      Kardiologische Gemeinschaftspraxis, Riesa,  -,  01587,  Germany
      Median Klinik, Bad Lausick,  -,  04651,  Germany
      Universität Rostock, Rostock,  -,  18055,  Germany
      Kardiologin, Dessau,  -,  06842,  Germany
Greece
      Kavala ,General Hospital, Kavala,  652 01,  Greece
      Gen. Hosp. of Chest Diseases "Sotiria", Athens,  11527,  Greece
      University Hospital of Ioannina, Ioannina,  45110,  Greece
      General Hospital of Korinthos, Korinthos,  20100,  Greece
      Laiko Hospital, Goudi/ Athens,  11527,  Greece
      Gen. Hosp. Melission "Amalia Fleming", Melissia, Athens,  151 27,  Greece
      Gen. Hosp. of Veria, Veria,  59100,  Greece
      Hippokratio Hospital of Thessaloniki, THESSALONIKI,  54639,  Greece
      General Hospital "Evangelismos", Athens,  10676,  Greece
      Hippokration Hospital, Athens,  11527,  Greece
      Kavala ,General Hospital, KAVALA,GREECE,  652 01,  Greece
      AHEPA Hospital, THESSALONIKI,  54636,  Greece
      Diagnostic & Therapeutic Centre of Athens "Hygea", Athens,  151 23,  Greece
      General Hospital "G. Genimatas", Athens,  156 69,  Greece
      Asclepion Voulas Hospital, Athens,  166 73,  Greece
Hong Kong
      Prince of Wales Hospital, Hong Kong,  Hong Kong
      Queen Mary Hospital, Hong Kong,  Hong Kong
      Department of Medicine & Geriatrics, Hong Kong,  Hong Kong
      Department of Medicine, Hong Kong,  Hong Kong
      Department of Medicine, Hong Kong,  Hong Kong
Hungary
      Szent György Hospital, Székesfehérvár,  8001,  Hungary
      Pécs Faculty of Medicine, Pécs,  7624,  Hungary
      MAV Hospital es Központi, Budapest,  1062,  Hungary
      Bács-Kiskun County Hospital, Kecskemét,  6000,  Hungary
      Siofok City Hospital, Siofok,  8601,  Hungary
      SE Egeszsegtudomanyi Kar, Budapest,  1135,  Hungary
      Jahn Frenc Del-Pesti Hospital, Budapest,  1204,  Hungary
      Budagyönygye Hospital, Budapest,  1021,  Hungary
      Sándor Péterfy Hospital, Budapest,  1076,  Hungary
      Szent Borbala Hospital, Tatabanya,  2801,  Hungary
      SE 3rd Internal Medical Clinic, Budapest,  1125,  Hungary
      Debrecen University, Debrecen,  4034,  Hungary
      Koranyi National Institute for TBC and Pulmonology, Budapest,  1529,  Hungary
      University of Szeged, Szeged,  6724,  Hungary
      National Institute of Cardiology, Budapest,  1096,  Hungary
      Varosi Eü. Szolgalat, Debrecen,  4032,  Hungary
      Josa Andras Hospital, Nyiregyhaza,  4400,  Hungary
      Szent Imre Hospital, Budapest,  1115,  Hungary
      FOUR-MED, Veszprem,  8200,  Hungary
      SE IInd Internal Medical Clinic, Budapest,  1088,  Hungary
Ireland
      Department of Genito Urinary Medicine, Dublin 8,  Ireland
      Adelaide and Meath Hospitals (incorrporating NCH), Dublin,  24,  Ireland
      PO Box 1297, Dublin,  9,  Ireland
Italy
      Ospedale Civile "S. Polo", MONFALCONE (GO),  34074,  Italy
      Ospedale di Città della Pieve, Città della Pieve (PG),  06062,  Italy
      Ospedale "S. Orsola Malpighi", Bologna,  40138,  Italy
      Ospedale "Mazzoni", Ascoli Piceno,  63100,  Italy
      Policlinico di Monteluce, Perugia,  06122,  Italy
      Azienda Ospedaliera di Caserta, Caserta,  81100,  Italy
      Istituto di Ricovero a Carattere Scientifico Neuromed- IRCCS, Pozzilli (IS),  86177,  Italy
      Ospedale Civile SS. Annunziata - USL 1, Sassari,  07100,  Italy
      Ospedale "R. Silvestrini", Perugia,  06124,  Italy
      Ospedale "N. Melli", S. Pietro Vernotico (BR),  72027,  Italy
      Ospedale Civile di Casarano, Casarano (LE),  73042,  Italy
      Policlinico Umberto I, Roma,  00161,  Italy
      Presidio Ospedaliero "Villa Sofia", Palermo,  90146,  Italy
      Azienda Universitaria Policlinico "Federico II", Napoli,  80131,  Italy
      IRCCS - Policlinico S. Matteo, Pavia,  27100,  Italy
      Arcispedale "S. Anna", Ferrara,  44100,  Italy
      Azienda Universitaria Policlinico II, Napoli,  80138,  Italy
      Università Federico II, Napoli,  80131,  Italy
      Policlinico di Tor Vergata, Roma,  00133,  Italy
      Ospedale di Bentivoglio, Bentivoglio (BO),  40010,  Italy
      Ospedale "S. Spirito", Roma,  00193,  Italy
      Ospedale Civile, Venezia,  30122,  Italy
      Ospedale di Circolo di Varese, Varese,  21100,  Italy
      A.O. "S. Camillo de Lellis", Roma,  00152,  Italy
      Ospedale "R. Silvestrini", Perugia,  06124,  Italy
      A.O. Spedali Civili di Brescia -Univ. degli studi di Brescia, Brescia,  25123,  Italy
      Ospedale Belcolle, Viterbo,  01100,  Italy
      A.S.O. "S. Giovanni Battista", Torino,  10126,  Italy
      Ospedale Bellaria, Bologna,  40139,  Italy
      ASL NA 1 - Distretto Sanitario di Base 53, Napoli,  80143,  Italy
Korea, Republic of
      St Paul''''s Hospital, Seoul,  Korea, Republic of
      Korea University Medical Center, Seoul,  Korea, Republic of
      Kyungpook National University Hospital, Taegu,  Korea, Republic of
      Dong-A University Hospital, Pusan,  Korea, Republic of
      Boehringer Ingelheim Investigational Site, Seoul,  Korea, Republic of
      Seoul National University Hospital, Seoul,  110-744,  Korea, Republic of
      Asan Medical Center, Seoul,  Korea, Republic of
      Seoul,  120-752,  Korea, Republic of
      Incheon Ghil Medical Center, Incheon,  Korea, Republic of
      Chonnam University Hospital, Kwang-ju,  Korea, Republic of
Malaysia
      Department of Medicine (Neurology), Kuala Lumpur,  50603,  Malaysia
      Faculty of Medicine, University of Malaya, Malaysia,  Malaysia
      Boehringer Ingelheim Investigational Site, Putrajaya,  62250,  Malaysia
      School of Medical Sciences, Malaysia,  Malaysia
      Institut Jantung Negara, Malaysia,  Malaysia
      Gleneagles Medical Center, Malaysia,  Malaysia
      Hospital Sultanah Aminah, Malaysia,  Malaysia
      Neuroscience Unit, Kelantan Darul Naim,  16150,  Malaysia
Netherlands
      Vasculair onderzoekscentrum (VOC), Hoorn,  1625 HV,  Netherlands
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands
New Zealand
      Green Lane Hospital, Auckland,  New Zealand
      Hawkes Bay Regional Hospital, Hasting,  New Zealand
      Ecom House, Auckland,  New Zealand
      North Shore Hospital, Takapuna Auckland,  New Zealand
      Christchurch Hospital, Christchurch,  New Zealand
      Promed House, Tauranga,  New Zealand
      Middlemore Hospital, Otahuhu Auckland,  New Zealand
      Waikato Hospital, Hamiton,  New Zealand
Norway
      Kardiologisk seksjon, Sentralsjukehuset i Rogaland, Stavanger,  N-4003,  Norway
      Lyngmyrveien 33, TVEDESTRAND,  N-4900,  Norway
      Feviktoppen, FEVIK,  N-4870,  Norway
      Fana Hjertesenter, NESTTUN,  N-5221,  Norway
      Med. avd., Vestfold Sentralsykehus, TØNSBERG,  N-3103,  Norway
      Ort. Kir.avd., Martina Hansens Hospital, ÆRUM POSTTERMINAL,  n-1306,  Norway
Philippines
      1st Floor, Section of Adult Medicine & Medical Research Unit, 1000 Manila,  Philippines
      Room 3 Annex, Manila,  Philippines
      Room 821, Quezon City,  Philippines
      Room 211, Pasig City,  Philippines
      Dept. of Physiology, Cavite,  Philippines
Philippines, PHILIPPINE
      East Avenue, Quezon City,  PHILIPPINE,  1100,  Philippines
Poland
      Municipal Hospital of Brudzinksi, Gdynia,  81 348,  Poland
      Municipal Hospital of Jonscher, Lodz,  93 113,  Poland
      Center of Medical Care, Jaroslawiec,  37 500,  Poland
      SPZOZ, Lubartow,  21 100,  Poland
      Hospital of Bieganskiego, Grudziadz,  86 300,  Poland
      III Klinika Kardiologii, Katowice-Ochojec,  40-635,  Poland
      Grojec Hospital, Grojec,  05-600,  Poland
      Provincial Unit Hospital, Kielce,  25-736,  Poland
      Grochowski Hospital, Warsaw,  04-073,  Poland
      Regional Hospital SPZOZ, Tomaszow Mazowiecki,  97-200,  Poland
      Regional Hospital, Piotrkow Trybunalski,  97-300,  Poland
      Sea Hospital im. PCK, Gdynia Redlowo,  81-519,  Poland
      Provincial Hospital, Skierniewice,  96 100,  Poland
      Municipal Hospital of Kopernika, Torun,  87 100,  Poland
      MSW Hospital, Bydgoszcz,  85 015,  Poland
      Municipal Hospital of T. Chalubinski, Czestochowa,  42 200,  Poland
      Hospital of Sw. Lukasza, Tarnow,  33-100,  Poland
      Department and Clinic of Cardiology AM, Warsaw,  02-097,  Poland
      Hospital Zespolony SP ZOZ, Nowy Sacz,  33-300,  Poland
      II Klinika Kardiologii, Pozna,  61-701,  Poland
      Spzital Wegrow, Wegrow,  07-100,  Poland
      Miedziowe Centrum Zdrowia, Lubin,  59-300,  Poland
      Szpital Powiatowy im Dr. L. Blazka, Inowroclaw,  88-100,  Poland
      Samodzielny Publiczny ZOZ Szpital, Ruda Slaska,  41-703,  Poland
Portugal
      Hospital de Santo António, Porto,  4100,  Portugal
      Hospital de Santa Maria, Lisboa,  1649-035,  Portugal
      Hospital de Santa Cruz, Carnaxide,  2795-563,  Portugal
      Hospital Distrital de Faro Geral, Faro,  8000,  Portugal
      Unidade Local de Saúde de Matosinhos, MATOSINHOS,  4454-509,  Portugal
      Hospitais da Universidade de Coimbra, Coimbra,  3000-075,  Portugal
      Centro Hospitalar vila Nova de Gaia, Vila Nova de Gaia,  4434-502,  Portugal
      Hospital de Santa Marta, Lisboa,  1150,  Portugal
      Hospital Fernando Fonseca, Amadora,  2700-276,  Portugal
Puerto Rico
      Orocovis Medical Center, Orocovis,  00720,  Puerto Rico
      Caguas,  00726,  Puerto Rico
      Policlinica Familiar Moncao, Manati,  00674,  Puerto Rico
      Centro Clinico San Patricio, Las Lomas,  00921,  Puerto Rico
      Miguel Sosa-Padilla, MD- Private Practice, Rio Piedras,  00926,  Puerto Rico
Russian Federation
      Russian Cardiology Research Center, Moscow,  121552,  Russian Federation
      National Endocrinology Research Center of Russia, Moscow,  117036,  Russian Federation
      President''''s Medical Center, Moscow,  121002,  Russian Federation
      President''''s Medical Center, Moscow,  129010,  Russian Federation
      Scientific Research Institute of Cardiology, St Petersburg,  194 156,  Russian Federation
      Military Medical Academy, St Petersburg,  194 156,  Russian Federation
      Russian Cardiology Research Center, Moscow,  121552,  Russian Federation
      Russian Cardiology Research Center, Moscow,  121552,  Russian Federation
      Russian Cardiology Research Center, Moscow,  121552,  Russian Federation
Singapore
      National Heart Center, Singapore,  168752,  Singapore
      Singapore General Hospital, Singapore,  169608,  Singapore
Slovakia
      Faculty Hospital L. Pasteura, Kosice,  04001,  Slovakia
      Faculty Hospital University Comenius, Bratislava,  81369,  Slovakia
      Faculty Hospital Nitra, Nitra,  94901,  Slovakia
      D & R s.r.o., Kosice,  040 22,  Slovakia
      Cardiology Ambulance, Rimavska Sobota,  97901,  Slovakia
South Africa
      Tiervlei Trial Centre, Bellville,  7531,  South Africa
      401 Medivaal Medical Centre, Vanderbijlpark,  1911,  South Africa
      5 Fichmed Centre, Bloemfontein,  9301,  South Africa
      101 Windsor Park, George,  6529,  South Africa
South Africa, GP
      Sunninghill Hospital, Sunninghill / Benmore,  GP,  2010,  South Africa
Spain
      Hospital Clínico Universitario, Valencia,  46010,  Spain
      Hospital Clínico Universitario, Alicante,  03010,  Spain
      Hospital Clínico Universitario, Alicante,  03010,  Spain
      Hospital de la Sta. Creu i Sant Pau, Barcelona,  08025,  Spain
      Hospital de la Santa Creu i Sant Pau, Barcelona,  08025,  Spain
      Hospital Vall d''''Hebrón, Barcelona,  08023,  Spain
      Fundació Gol i Gurina, Barcelona,  08007,  Spain
      Hospital Clínico y Provincial de Barcelona, Barcelona,  08036,  Spain
      Hospital Clínico San Cecilio, Granada,  18012,  Spain
      Hospital Clínico San Cecilio, Granada,  18012,  Spain
      Hospital Ramón y Cajal, Madrid,  28034,  Spain
      Hospital Ramón y Cajal, Madrid,  28034,  Spain
      Hospital 12 de Octubre, Madrid,  28041,  Spain
      Hospital Clínico San Carlos, Madrid,  28040,  Spain
      Hospital La Paz, Madrid,  28046,  Spain
      Hospital de Alcorcón, Alcorcón (Madrid),  28922,  Spain
      Hospital Vírgen de la Victoria, Málaga,  29010,  Spain
      Hospital Carlos Haya, Málaga,  29010,  Spain
      Centro de Salud San Andrés, Murcia,  30005,  Spain
      Hospital del Conxo, Santiago de Compostela,  15706,  Spain
      Hospital Clínico Universitario, Santiago de Compostela,  15705,  Spain
      Hospital Clínico Universitario, Santiago de Compostela,  15705,  Spain
      Hospital Virgen de la Macarena, Sevilla,  41071,  Spain
      Centro de Salud Burjassot, Burjasot (Valencia),  46010,  Spain
      Hospital Clínico Universitario, Valencia,  46010,  Spain
      Hospital Clínico Universitario, Valencia,  46010,  Spain
      Hospital Clínico Universitario, Alicante,  03010,  Spain
      Hospital Clínico Universitario, Alicante,  03010,  Spain
      Hospital Carlos Haya, Málaga,  29010,  Spain
Sweden
      Stortorget 13, Helsingborg,  252 20,  Sweden
      Albinsrogatan 1A, Malmö,  214 67,  Sweden
      Birgittavägen 4, Järfälla,  17731,  Sweden
      Lundby sjukhus, Göteborg,  411 17,  Sweden
      Kardiologen, Malmö,  205 02,  Sweden
      Balzargatan 41 A, Malmö,  211 36,  Sweden
      Sahlgrenska Universitetssjukhuset/Östra, Göteborg,  416 85,  Sweden
      Hjärtkärl Institutet, Göteborg,  413 45,  Sweden
Switzerland
      Universitätsspital Basel, Medizinische Poliklinik, Basel,  4031,  Switzerland
      Boehringer Ingelheim Investigational Site, Lugano,  6900,  Switzerland
      Universitätsspital Zürich, ZÜRICH,  CH-8091,  Switzerland
      Kantonsspital, Chur,  7000,  Switzerland
      Ospedale San Giovanni, Bellinzona,  6500,  Switzerland
      Inselspital Bern, Bern,  3010,  Switzerland
      DIM / Abteilung für Infektiologie, St. Gallen,  9007,  Switzerland
      Boehringer Ingelheim Investigational Site, Biel/Bienne,  2500,  Switzerland
      Herz-Zentrum Bodensee, Kreuzlingen,  8280,  Switzerland
      Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429, Lausanne,  1011,  Switzerland
Taiwan
      National Cheng Kung University Hospital, Taiwan,  Taiwan
      Chang Gung Memorial Hospital-Kaohsiung, Taiwan,  Taiwan
      Chi-Mei Foundation Hospital, Taiwan,  Taiwan
      Kaohsiung Medical University Hospital, Taiwan,  Taiwan
      Chia Yi Christian Hospital, Taiwan,  Taiwan
      Chang-Hwa Christian Hospital, Taiwan,  Taiwan
      Shin Kong Wu Ho-Su Memorial Hospital, Taiwan,  Taiwan
      Cathay General Hospital, Taiwan,  Taiwan
      Buddhist Tzu Chi General Hospital, Taiwan,  Taiwan
Thailand
      Siriraj Hospital, Thailand,  Thailand
      Bhumiphol Hospital, Thailand,  Thailand
      Srinagarind Hospital, Pulmonary Div., Khon Kaen,  40002,  Thailand
      Ramathibodi Hospital, Thailand,  Thailand
      Chulalongkorn Hospital, Thailand,  Thailand
      Pramonkutklao Hospital, Bangkok, Thailand,  Thailand
      Central Chest Hospital, Cardiology Unit, Nonthaburi, Thailand,  Thailand
      Bangkok General Hospital, Bangkok, Thailand,  Thailand
Turkey
      Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali, KAYSERI,  Turkey
      Cukurova Universitesi Tip Fakultesi, Adana,  Turkey
      Cukurova Universitesi Tip Fakultesi, Adana,  Turkey
      Ankara Hastanesi Endokrinoloji Bölümü, Ankara,  Turkey
      Göztepe SSK Egitim ve Arastirma Hastanesi, Istanbul,  Turkey
      Cerrahpasa Universitesi Tip Fakultesi, Istanbul,  Turkey
      Baskent Universitesi Tip Fakultesi, Ankara,  Turkey
      Haseki Hastanesi, Istanbul,  Turkey
      Ege Universitesi Tip Fakultesi, Izmir,  Turkey
      Ankara Universitesi Tip Fakultesi, Ankara,  Turkey
Ukraine
      Institute of Cardiology, Kiev,  03151,  Ukraine
      Institute of Cardiology, Kiev,  03151,  Ukraine
      Central Clinical Hospital, Kiev,  01023,  Ukraine
      Research Institute of Therapy, Kharkov,  61039,  Ukraine
      Institute of Cardiology, Kiev,  03151,  Ukraine
      Dnyepropyetrovsk Medical Academy, Dnyepropetrovsk,  49044,  Ukraine
      Dnyepropyetrovsk Medical Academy, Dnyepropetrovsk,  49044,  Ukraine
      City Clinical Hospital No. 27, Kharkov,  61002,  Ukraine
      Central Railway Hospital, Kiev,  03680,  Ukraine
      Municipal Institute of Health Care, Kharkov,  61091,  Ukraine
United Kingdom
      Royal Victoria Hospital, Belfast,  BT12 6BA,  United Kingdom
      Level 6, Leeds,  LS1 3EX,  United Kingdom
      Diabetes Centre, Rugby,  CV22 5PX,  United Kingdom
      Dept of Medicine, Manchester,  M13 9WL,  United Kingdom
      Department of Respiratory Medicine, Birmingham,  B9 5SS,  United Kingdom
      Kings Cross Hospital (Dulwich), London,  SE22 8PT,  United Kingdom
      Royal Hallamshire Hospital, Sheffield,  S10 2JF,  United Kingdom
      Liverpool,  L7 8XP,  United Kingdom
      University of Leicester, Leicester,  LE2 7LX,  United Kingdom
      Lincoln,  LN2 5QY,  United Kingdom
      Bathampton Surgery, Bathampton,  BA2 6UL,  United Kingdom
      St Richards Hospital, Chichester, West Sussex,  PO19 4SE,  United Kingdom
United Kingdom, CA
      Lucille Packard Children''''s Health Services at Stanford, Palo Alto,  CA,  94304-5786,  United Kingdom
United Kingdom, FIFE
      Victoria Hospital, Kirkcaldy,  FIFE,  KY2 5AH,  United Kingdom
United Kingdom, N.IRELAND
      Craigavon Area Hospital, County Antrim,  N.IRELAND,  BT66 5QQ,  United Kingdom
United Kingdom, SCOTLAND
      Neurology Department, Glasgow,  SCOTLAND,  G51 4TF,  United Kingdom
      Ward 6, Aberdeen,  SCOTLAND,  AB9 2ZB,  United Kingdom
      Department of General Medicine, Stirling,  SCOTLAND,  FK8 2AU,  United Kingdom
United Kingdom, TYNE & WEA
      Gateshead,  TYNE & WEA,  NE9 6SX,  United Kingdom
United Kingdom, W SUSSEX
      Cardiac Research, Brighton,  W SUSSEX,  BN2 1ES,  United Kingdom

Study chairs or principal investigators

Lutz Hilbrich, Dr.,  Study Chair,  B.I. Pharma GmbH & Co. KG   

Study ID Numbers:  502.373
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00153101
Health Authority: Argentina: National Administration of Medicines, Food and Medical Technology; Austria: Bundesministerium f. Gesundheit und Frauen Sektion III - Gesundheitswesen; Australia New Zealand: Therapeutic Goods Administration; Belgium: SPF; Brazil: Gerente de Medicamentos Novos, Pesquisa e Ensaios Clínicos - ANVISA; Canada: Health Canada; China: State Food and