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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg
* Drug: valsartan 160 mg / hydrochlorothiazide 25 mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent. Age 18 years or older Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion) Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline) Exclusion Criteria: 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). Known or suspected secondary hypertension. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization. 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. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume depletion. Uncorrected sodium depletion. Primary aldosteronism. Hereditary fructose intolerance. Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists. History of drug or alcohol dependency within six months prior to start of run-in period. Chronic administration of any medications known to affect blood pressure, exc

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg|nan|
|Drug: valsartan 160 mg / hydrochlorothiazide 25 mg|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean seated trough cuff DBP and SBP |  | after 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements |  | after 8 week | 
| The percentage of patients with uncontrolled hypertension |  | after 8 weeks | 
| Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points |  | after 8 weeks |