Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients

Study Overview
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Brief Summary
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A double-blind, active-controlled, randomized trial to compare Valsartan plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg. Study design: 2 weeks washout, 8 weeks treatment period.

Official Title
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The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan plus Hydrochlorothiazide (80mg/12.5mg)
* Drug: Amlodipine (5mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patient with age ≧ 18 years old. Patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment. Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure (sDBP) ≦ 180/110 mmHg at screening visit. For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient, sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure (sDBP) ≧ 80 mmHg at baseline visit. Patient or his/her legally acceptable representative has signed and dated the informed consent form. Exclusion Criteria: Known or suspected secondary hypertension. sSBP > 180 mmHg or sDBP > 110 mmHg at baseline visit. Patients taking more than two anti-hypertensive medications at the screening visit. (Fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.) Known NYHA functional class Chronic Heart Failure (CHF) III and IV. With a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters SGPT (ALT) or SGOT (AST) > two times upper the limit of normal range Serum creatinine > 2.3 mg/dl or creatinine clearance < 30 ml/min 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

| Intervention/Treatment |
| --- |
|Drug: Valsartan plus Hydrochlorothiazide (80mg/12.5mg)|nan|
|Drug: Amlodipine (5mg)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment |  |  | 
| Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure