Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

Official Title
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A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan/Hydrochlorothiazide
* Drug: HCTZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age and older Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg Exclusion Criteria: - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure. Other protocol-defined inclusion/exclusion criteria may apply.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: valsartan HCTZ<br> | Drug: Valsartan/Hydrochlorothiazide<br>* 160/12.5 mg taken once daily orally<br>* Other names: Co-Diovan, Diovan HCT;|
| Active Comparator: HCTZ<br> | Drug: HCTZ<br>* 25 mg taken once daily orally<br>* Other names: hydrochlorothiazice, water pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks |  |  | 
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 2 weeks and 4 weeks |  |  | 
| Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks |  |  | 
| Change in systolic blood pressure at 20 weeks compared to 4 weeks |  |  | 
| Change in diastolic blood pressure at 20 weeks compared to 4 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, High blood pressure, diuretics, valsartan