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

Novartis871 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

871

Conditions

Essential Hypertension Hypercholesterolemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Low density lipoproteins after 6 weeks

Secondary Outcomes

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