A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential 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

871 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

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The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.

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Detailed Description

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Conditions

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Essential Hypertension Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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simvastatin

Intervention Type DRUG

valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elevated LDL-Cholesterol
* Essential hypertension

Exclusion Criteria

* Severe Hypertension
* Prior or known muscular or neuromuscular disease of any type
* A history of cardiovascular disease
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes or insulin treatment
* Evidence of hepatic or renal disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No