The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Condition	Intervention	Phase
Hypertension	Drug: placebo  Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg  Drug: valsartan 160 mg / hydrochlorothiazide 25 mg	Phase IV

Further Study Details: 

Primary Outcomes: Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Secondary Outcomes: Change from baseline in seated peak (1 and 3 hours post dose) cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Expected Total Enrollment:  1125

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria

1. Ability to provide written informed consent.
2. Age 18 years or older
3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator''''s discretion)
4. Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)

Exclusion criteria

1. Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:

   1. are not surgically sterile; and/or
   2. are nursing or pregnant
   3. are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
2. Known or suspected secondary hypertension.
3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.

4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

   1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
   2. Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
6. Clinically relevant hypokalemia or hyperkalemia.
7. Uncorrected volume depletion.
8. Uncorrected sodium depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic insufficiency.
12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
13. History of drug or alcohol dependency within six months prior to start of run-in period.
14. Chronic administration of any medications known to affect blood pressure, exc

Please refer to this study by ClinicalTrials.gov identifier  NCT00168779

Boehringer Ingelheim Study Coordinator      +1 (614) 241-4107 

Alabama
      Boehringer Ingelheim Investigational Site, Huntsville,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Huntsville,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Mobile,  Alabama,  United States
      Boehringer Ingelheim Investigational Site, Birmingham,  Alabama,  United States
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      Boehringer Ingelheim Investigational Site, Athens,  Alabama,  United States
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Arizona
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Arkansas
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Colorado
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Connecticut
      Boehringer Ingelheim Investigational Site, Farmington,  Connecticut,  United States
Delaware
      Boehringer Ingelheim Investigational Site, Newark,  Delaware,  United States
Florida
      Boehringer Ingelheim Investigational Site, Pembroke Pines,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Ft. Lauderdale,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Panama City,  Florida,  United States
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      Boehringer Ingelheim Investigational Site, Coral Gables,  Florida,  United States
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      Boehringer Ingelheim Investigational Site, Hollywood,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Largo,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Kissimmee,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Pembroke Pines,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Melbourne,  Florida,  United States
      Boehringer Ingelheim Investigational Site, Deland,  Florida,  United States
Georgia
      Boehringer Ingelheim Investigational Site, Conyers,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Atlanta,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Atlanta,  Georgia,  United States
      Boehringer Ingelheim Investigational Site, Decatur,  Georgia,  United States
Illinois
      Boehringer Ingelheim Investigational Site, Peoria,  Illinois,  United States
      Boehringer Ingelheim Investigational Site, Chicago,  Illinois,  United States
      Boehringer Ingelheim Investigational Site, Chicago,  Illinois,  United States
Indiana
      Boehringer Ingelheim Investigational Site, Indianapolis,  Indiana,  United States
      Boehringer Ingelheim Investigational Site, Evansville,  Indiana,  United States
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Kansas
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      Boehringer Ingelheim Investigational Site, Newton,  Kansas,  United States
Kentucky
      Boehringer Ingelheim Investigational Site, Louisville,  Kentucky,  United States
      Boehringer Ingelheim Investigational Site, Erlanger,  Kentucky,  United States
Louisiana
      Boehringer Ingelheim Investigational Site, New Orleans,  Louisiana,  United States
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Maryland
      Boehringer Ingelheim Investigational Site, Oxon Hill,  Maryland,  United States
Michigan
      Boehringer Ingelheim Investigational Site, Troy,  Michigan,  United States
Minnesota
      Boehringer Ingelheim Investigational Site, Brooklyn Center,  Minnesota,  United States
      Boehringer Ingelheim Investigational Site, Edina,  Minnesota,  United States
      Boehringer Ingelheim Investigational Site, St. Paul,  Minnesota,  United States
Missouri
      Boehringer Ingelheim Investigational Site, Kansas City,  Missouri,  United States
      Boehringer Ingelheim Investigational Site, Kansas City,  Missouri,  United States
      Boehringer Ingelheim Investigational Site, St. Louis,  Missouri,  United States
Nebraska
      Boehringer Ingelheim Investigational Site, Omaha,  Nebraska,  United States
      Boehringer Ingelheim Investigational Site, Omaha,  Nebraska,  United States
Nevada
      Boehringer Ingelheim Investigational Site, Las Vegas,  Nevada,  United States
      Boehringer Ingelheim Investigational Site, Las Vegas,  Nevada,  United States
New Jersey
      Boehringer Ingelheim Investigational Site, Ship Bottom,  New Jersey,  United States
      Boehringer Ingelheim Investigational Site, Turnersville,  New Jersey,  United States
      Boehringer Ingelheim Investigational Site, Berlin,  New Jersey,  United States
New York
      Boehringer Ingelheim Investigational Site, Northport,  New York,  United States
      Boehringer Ingelheim Investigational Site, Rochester,  New York,  United States
      Boehringer Ingelheim Investigational Site, Brooklyn,  New York,  United States
      Boehringer Ingelheim Investigational Site, Williamsville,  New York,  United States
      Boehringer Ingelheim Investigational Site, Syracuse,  New York,  United States
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North Carolina
      Boehringer Ingelheim Investigational Site, Winston Salem,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Raleigh,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Burlington,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Charlotte,  North Carolina,  United States
      Boehringer Ingelheim Investigational Site, Winston Salem,  North Carolina,  United States
Ohio
      Boehringer Ingelheim Investigational Site, Columbus,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Columbus,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Cincinnati,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Cincinnati,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Kettering,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Olmstead Township,  Ohio,  United States
      Boehringer Ingelheim Investigational Site, Columbus,  Ohio,  United States
Oklahoma
      Boehringer Ingelheim Investigational Site, Oklahoma City,  Oklahoma,  United States
      Boehringer Ingelheim Investigational Site, Tulsa,  Oklahoma,  United States
      Boehringer Ingelheim Investigational Site, Oklahoma City,  Oklahoma,  United States
Oregon
      Boehringer Ingelheim Investigational Site, Salem,  Oregon,  United States
      Boehringer Ingelheim Investigational Site, Portland,  Oregon,  United States
Pennsylvania
      Boehringer Ingelheim Investigational Site, Collegeville,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Philadelphia,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Springfield,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Harleysville,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Erie,  Pennsylvania,  United States
      Boehringer Ingelheim Investigational Site, Penndel,  Pennsylvania,  United States
Rhode Island
      Boehringer Ingelheim Investigational Site, East Providence,  Rhode Island,  United States
South Carolina
      Boehringer Ingelheim Investigational Site, Columbia,  South Carolina,  United States
Tennessee
      Boehringer Ingelheim Investigational Site, New Tazewell,  Tennessee,  United States
      Boehringer Ingelheim Investigational Site, Selmer,  Tennessee,  United States
      Boehringer Ingelheim Investigational Site, Cordova,  Tennessee,  United States
      Boehringer Ingelheim Investigational Site, Jackson,  Tennessee,  United States
      Boehringer Ingelheim Investigational Site, Nashville,  Tennessee,  United States
Texas
      Boehringer Ingelheim Investigational Site, Carrolton,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Dallas,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Dallas,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Dallas,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Harker Heights,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Dallas,  Texas,  United States
      Boehringer Ingelheim Investigational Site, Miles,  Texas,  United States
Utah
      Boehringer Ingelheim Investigational Site, Bountiful,  Utah,  United States
      Boehringer Ingelheim Investigational Site, Salt Lake City,  Utah,  United States
      Boehringer Ingelheim Investigational Site, Salt Lake City,  Utah,  United States
      Boehringer Ingelheim Investigational Site, Sandy,  Utah,  United States
      Boehringer Ingelheim Investigational Site, Sandy,  Utah,  United States
Virginia
      Boehringer Ingelheim Investigational Site, Falls Church,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Norfolk,  Virginia,  United States
      Boehringer Ingelheim Investigational Site, Virginia Beach,  Virginia,  United States
Washington
      Boehringer Ingelheim Investigational Site, Tacoma,  Washington,  United States
West Virginia
      Boehringer Ingelheim Investigational Site, Charlston,  West Virginia,  United States
Wisconsin
      Boehringer Ingelheim Investigational Site, Milwaukee,  Wisconsin,  United States
      Boehringer Ingelheim Investigational Site, Menomonee Falls,  Wisconsin,  United States

Study chairs or principal investigators

Boehringer Ingelheim Study Coordinator,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  502.476
Last Updated:  September 19, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00168779
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20