A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia

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

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..

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Detailed Description

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Conditions

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HYPERTENSION HYPERCHOLESTEROLEMIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan + simvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ESSENTIAL HYPERTENSION
* ELEVATED LDL-C CHOLESTEROL
* USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS

Exclusion Criteria

* SEVERE HYPERTENSION
* EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
* HISTORY OF STROKE OR MYOCARDIAL INFARCTION
* DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
* UNCONTROLLED DIABETES OR INSULIN

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No