A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia

Condition(s) targeted: Hypertension; Hypercholesterolemia

Intervention: valsartan + simvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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..

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change in average ambulatory systolic blood pressure over 24 hours

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Novartis Pharmaceuticals, E. Hanover, New Jersey 07936, United States

Starting date: September 2004
Last updated: August 6, 2007