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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Essential Hypertension

Treatments: Drug: valsartan; Drug: simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254475

CVAS489A2403

Details and patient eligibility

About

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.

Enrollment: 871 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind