Overview

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

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Simvastatin
Valsartan
Criteria
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