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

Novartis

Status and phase: Completed; Phase 3

Conditions: HYPERTENSION; HYPERCHOLESTEROLEMIA

Treatments: Drug: valsartan + simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171093

CVAS489A2316

Details and patient eligibility

About

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..

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind