A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valsartan + amlodipine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients (18 years)
2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II)

Exclusion Criteria

1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg)
4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No