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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254475
• Other study ID #: CVAS489A2403
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2005
• Last updated: August 18, 2014
• Start date: November 2005
• Est. completion date: September 2006

Study information

• Verified date: August 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 871
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• simvastatin

• valsartan

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density lipoproteins after 6 weeks
Secondary	Lipid profile at 6, 12 wks
Secondary	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
Secondary	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
Secondary	Systolic and diastolic bp at 6, 12 wks
Secondary	Serious/adverse events, labs, physical exams, vitals up to 12 wks