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

A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00254475

Enrollment

871

Registered

2005-11-16

Start date

2005-11-30

Completion date

2006-09-30

Last updated

2014-08-19

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

Conditions

Essential Hypertension, Hypercholesterolemia

Keywords

Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker

Brief summary

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.

Interventions

DRUGsimvastatin

DRUGvalsartan

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Low density lipoproteins after 6 weeks	—

Secondary

Measure	Time frame
Lipid profile at 6, 12 wks	—
BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks	—
SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks	—
Systolic and diastolic bp at 6, 12 wks	—
Serious/adverse events, labs, physical exams, vitals up to 12 wks	—

Countries

Germany, Switzerland

Outcome results

None listed

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