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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/30/2017
Start Date:September 2005
End Date:July 2006

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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 With Stage 1 or Stage 2 Hypertension.

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.


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
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