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A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240448
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 5, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: telmisartan 80 mg/hydrochlorothiazide 25 mg Drug: valsartan 160 mg/hydrochlorothiazide 25 mg Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of MICARDIS® HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus DIOVAN® HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and Stage 2 Hypertension
Study Start Date : September 2003
Actual Primary Completion Date : June 2004

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    • Are not surgically sterile and/or
    • Are nursing or pregnant
    • 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:

    • SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
    • 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, cholestasis 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, etc.
  15. Any investigational drug therapy within one month of start of run-in period.
  16. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
  17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
  18. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
  19. Night shift workers.
  20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
  21. NYHA functional class CHF III-IV.
  22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.
  24. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
  25. History of non-compliance with prescribed medication or protocol procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240448

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Layout table for additonal information Identifier: NCT00240448    
Other Study ID Numbers: 502.421
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators