A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia

Novartis1 site in 1 country369 target enrollmentSeptember 2004

ConditionsHYPERTENSION HYPERCHOLESTEROLEMIA

Drugsvalsartan + simvastatin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HYPERTENSION
Sponsor: Novartis
Enrollment: 369
Locations: 1
Primary Endpoint: Change in average ambulatory systolic blood pressure over 24 hours
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

January 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•ESSENTIAL HYPERTENSION
•ELEVATED LDL-C CHOLESTEROL
•USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS

Exclusion Criteria

•SEVERE HYPERTENSION
•EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
•HISTORY OF STROKE OR MYOCARDIAL INFARCTION
•DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
•UNCONTROLLED DIABETES OR INSULIN
•Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Change in average ambulatory systolic blood pressure over 24 hours

Change in serum low density lipoprotein cholesterol (LDL-C )

Secondary Outcomes

Adverse events and serious adverse events at each study visit for 42 days
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days