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

A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171093

Enrollment

369

Registered

2005-09-15

Start date

2004-09-30

Completion date

Unknown

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HYPERCHOLESTEROLEMIA, HYPERTENSION

Keywords

HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN

Brief summary

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..

Interventions

DRUGvalsartan + simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Change in average ambulatory systolic blood pressure over 24 hours	—
Change in serum low density lipoprotein cholesterol (LDL-C )	—

Secondary

Measure	Time frame
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime	—
Adverse events and serious adverse events at each study visit for 42 days	—
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days	—
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication	—
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026