The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

Condition	Intervention	Phase
Hypertension	Drug: Telmisartan/hydrochlorothiazide fixed-dose combination (dose 80mg+25mg)	Phase III

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcomes: The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. 24 hours after last dose) at six months of treatment.
Secondary Outcomes: The secondary efficacy endpoint variables include a range of blood pressure measurements e.g. seated trough systolic blood pressure. Safety (vital signs, laboratory values, physical examination and ECG findings) will also be assessed.
Expected Total Enrollment:  480

Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All patients will receive T80/H25. Additional antihypertensive therapy will be allowed if the patients'''' blood pressure is not well controlled. [In the preceding double-blind trial 502.480, patients who failed to respond to the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 12.5 mg (T80/H12.5) were randomised to T80/H12.5 or T80H25 for eight weeks.] This is a multi-centre, multinational trial with approximately 80 study centres participating. Only study centres participating in the preceding trial 502.480 can enter patients into this open-label trial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen countries. Each trial centre is expected to enter between four and twenty-four patients.

Enrolment of patients into this trial will finish when the last patient completes the preceding trial 502.480. At this time, centres will be notified of the termination of recruitment and will not be authorized to include any further patients.

Patients will visit the clinic one month, three months and six months later for assessment of their blood pressure and general health. Their participation in the study is complete six months after the start of the treatment period.

Study Hypothesis:

No statistical hypothesies will be tested. Descriptive statistics will be used to characterise the effects of treatment with T80/H25 with and without other antihypertensive treatments.

Comparison(s):

The proportion of patients achieving DBP control will be summarised by the total number of patients in the trial as well as by the maximum achieved dose level according to the two categories of T80/H25 alone (T80/H25) and with other antihypertensive medication added (T80/H25/other). An additional sub-group summary by the treatment group in the preceding trial 502.480 (T80/H12.5 and T80/H25) will also be presented.

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

essential hypertension. currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1.

blood pressure not adequately controlled on existing treatment before entry (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medications).

failure to respond to six weeks treatment with T80/H12.5. (Failure to respond defined as seated DBP >= 90 mmHg at six weeks. This criterion will be assessed at Visit 3.) willing and able to provide written informed consent.

Exclusion criteria:

women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.

known or suspected secondary hypertension. mean SBP >= 200 mmHg. severe hepatic or renal impairment bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.

clinically relevant hypokalaemia or hyperkalaemia. uncorrected volume or sodium depletion, primary aldosteronism. hereditary fructose intolerance. previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.

drug or alcohol dependency within the previous six months. administration of any medication known to affect blood pressure. concurrent participation in another clinical trial or any investigational therapy.

hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.

allergic hypersensitivity to any component of the formulations under investigation.

concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (less than 80% or more than 120%) during the run-in treatment period.

any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.

Please refer to this study by ClinicalTrials.gov identifier  NCT00267943

Boehringer Ingelheim Study Coordinator      +353 (1) 295-9620  Ext. 2959620 

Denmark
      Boehringer Ingelheim Investigational Site, Rødovre,  DK-2610,  Denmark
      Boehringer Ingelheim Investigational Site, Birkerød,  3460,  Denmark
      Boehringer Ingelheim Investigational Site, Odense SØ,  DK-5220,  Denmark
      Boehringer Ingelheim Investigational Site, Odder,  8300,  Denmark
      Boehringer Ingelheim Investigational Site, Vildbjerg,  DK-7480,  Denmark
      Boehringer Ingelheim Investigational Site, Haderslev,  DK-6100,  Denmark
Finland
      Turun yliopistollinen keskussairaala, Sisätautien klinikka, Turku,  FI-20520,  Finland
      Suomen Terveystalo Oyj/Verkahovin Lääkäriasema, Turku,  FI-20100,  Finland
      Itä-Suomen Lääkärikeskus Oy, Joensuu,  FI-80100,  Finland
      Joensuun Hoitoasema Oy, Joensuu,  FI-80100,  Finland
      Keski-Pohjanmaan keskussairaala, Sisätaudit, Kokkola,  FI-67200,  Finland
      Lääkärikeskus Mehiläinen/Ympyrätalo, Helsinki,  FI-00500,  Finland
France
      Hôpital Avicenne, Bobigny,  93000,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      Mg Recherches, Paris,  75015,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      ALTI, Angers,  49000,  France
      Mg Recherches, Paris,  75015,  France
Germany
      Boehringer Ingelheim Investigational Site, Unterschneidheim,  73485,  Germany
      ROBEMA Clinical Research GmbH, Frankfurt/Main,  60323,  Germany
      Boehringer Ingelheim Investigational Site, Rodgau-Dudenhofen,  63110,  Germany
      Boehringer Ingelheim Investigational Site, Flörsheim,  65439,  Germany
      Boehringer Ingelheim Investigational Site, Haag,  83527,  Germany
      Boehringer Ingelheim Investigational Site, Nürnberg,  90402,  Germany
      Boehringer Ingelheim Investigational Site, Ellefeld,  08236,  Germany
      Boehringer Ingelheim Investigational Site, Ingelheim,  55218,  Germany
Hong Kong
      Queen Mary Hospital, Hong Kong,  Hong Kong
      Prince of Wales Hospital, Hong Kong,  Hong Kong
Ireland
      Beaumont Woods, Dublin,  9,  Ireland
      Aylesbury Health Centre, Dublin,  24,  Ireland
      The Park Clinic, Dublin,  18,  Ireland
Korea, Republic of
      Korea University Guro Hospital, Seoul,  152703,  Korea, Republic of
      CENTER/Div. of Cardiology/Heart Center, Incheon,  405760,  Korea, Republic of
      Kangdong Sacred Heart Hospital, Seoul,  134701,  Korea, Republic of
Malaysia
      Sarawak General Hospital, Kuching Sarawak,  93586,  Malaysia
Netherlands
      Boehringer Ingelheim Investigational Site, Rijswijk,  2281 AK,  Netherlands
      Boehringer Ingelheim Investigational Site, Roelofarendsveen,  2371 RB,  Netherlands
      Boehringer Ingelheim Investigational Site, BENNEBROEK,  2121 BB,  Netherlands
      Boehringer Ingelheim Investigational Site, Ewijk,  6644 CL,  Netherlands
      Boehringer Ingelheim Investigational Site, Nijverdal,  7441 BN,  Netherlands
      Boehringer Ingelheim Investigational Site, Hoogwoud,  1817 BG,  Netherlands
      Boehringer Ingelheim Investigational Site, Rotterdam,  3082 DC,  Netherlands
      Boehringer Ingelheim Investigational Site, Oude Pekela,  9665 BJ,  Netherlands
      Boehringer Ingelheim Investigational Site, Oude Pekela,  9665 AR,  Netherlands
Singapore
      National Heart Centre, Singapore,  168752,  Singapore
      Changi General Hospital, Singapore,  529889,  Singapore
South Africa
      Health Emporium, Midrand,  1685,  South Africa
      Boehringer Ingelheim Investigational Site, Pretoria,  0038,  South Africa
      Suite DF3, Johannesburg,  South Africa
      Boehringer Ingelheim Investigational Site, Lenasia,  2033,  South Africa
      Boehringer Ingelheim Investigational Site, Durban,  4091,  South Africa
      Boehringer Ingelheim Investigational Site, Cape Town,  7531,  South Africa
      Dept of Cardiology, Johannesburg,  2013,  South Africa
      Dept of Medicine, Johannesburg,  South Africa
Spain
      Hospital Gral de Jerez de la Frontera, Jerez de la Frontera / Cádiz,  11407,  Spain
      C.A.P. Ronda Cerdanya, Mataró / Barcelona,  08303,  Spain
      Hospital de Galdakao, Galdakao-Vizcaya,  48680,  Spain
      Hospital Univ. Gregorio Marañón, Madrid,  28007,  Spain
      C.A.P. Mosen Cinto Verdaguer, L''''Hospitalet de Llobregat / Barcelona,  08902,  Spain
      Hospital del Conxo, Santiago de Compostela,  15706,  Spain
      Hospital General de Móstoles - Medicina Interna, Móstoles / Madrid,  28935,  Spain
      Hospital Municipal de Badalona, Badalona,  08911,  Spain
Sweden
      Medicinkliniken, Karlstad,  651 85,  Sweden
      Boehringer Ingelheim Investigational Site, Uddevalla,  451 40,  Sweden
      Boehringer Ingelheim Investigational Site, Eksjö,  575 36,  Sweden
      Boehringer Ingelheim Investigational Site, Karlstad,  652 24,  Sweden
      Samariterhemmets sjukhus, Uppsala,  751 25,  Sweden
Switzerland
      Universitätsspital Basel, Basel,  4031,  Switzerland
      Boehringer Ingelheim Investigational Site, Basel,  4052,  Switzerland
      Boehringer Ingelheim Investigational Site, Basel,  4051,  Switzerland
      Herz-Zentrum Bodensee, Kreuzlingen,  8280,  Switzerland
      Inselspital Bern, Bern,  3010,  Switzerland
      Boehringer Ingelheim Investigational Site, Gland,  1196,  Switzerland
      Boehringer Ingelheim Investigational Site, Petit-Lancy,  1213,  Switzerland
      Boehringer Ingelheim Investigational Site, Bulle,  1630,  Switzerland
      Boehringer Ingelheim Investigational Site, St.Maurice,  1890,  Switzerland
      Boehringer Ingelheim Investigational Site, St-Imier,  2610,  Switzerland
      Boehringer Ingelheim Investigational Site, Renens VD,  1020,  Switzerland
      Boehringer Ingelheim Investigational Site, Vezia,  6940,  Switzerland
      Ospedale San Giovanni, Bellinzona,  6500,  Switzerland
Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan
      Mackay Memorial Hospital, Taipei,  104,  Taiwan
      Taipei Veterans General Hospital, Taipei,  112,  Taiwan

Study chairs or principal investigators

Boehringer Ingelheim Study Coordinator,  Study Chair,  BIL UK / Ireland   

Study ID Numbers:  502.491
Last Updated:  December 21, 2005
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00267943
Health Authority: Denmark: Laegemiddelstyrelsen Clinical Studies; Finland: Lääkelaitos, National Agency for Medicines; France: French Medicine Agency (AFSSAPS); Germany: Bundesministerium für Arzneimittel und Medizinprodukte; Hong Kong: Department of Health, Pharmaceutical Registration and Import/Export Control Section, Hong Kong; Ireland: Irish Medicines Board; Italy: Comitato Etico dell''''Azienda Ospedaliera "Arcispedale Sant''''Anna" - Università di Ferrara; Korea: Korean Food and Drug Administration; Malaysia: National Pharmaceutical Control Bureau, Malaysia; Norway: Statens Legemiddelverk; Singapore: Centre for Pharmaceutical Administration, Health Science Authority; South Africa: Medicines Control Council; Spain: Agencia Española del Medicamento; Sweden: Läkemedelsverket; Switzerland: Swissmedic; Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10