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Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00168779
  Purpose

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

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Valsartan Hydrochlorothiazide Telmisartan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients Iwth Stage 1 or Stage 2 Hypertension

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period [ Time Frame: 8 week ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8 week ]

Estimated Enrollment: 1125
Study Start Date: September 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 in sufficiency.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168779

  Show 113 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.476
Study First Received: September 12, 2005
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00168779  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Vascular Diseases
Telmisartan
Angiotensin II
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009