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

Phase 3

Completed

• Conditions: Essential Hypertension; Hypercholesterolemia

• Registration Number: NCT00254475
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-07
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-16
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Low density lipoproteins after 6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland