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”

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..

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: valsartan + simvastatin

Primary Measures

• Change in average ambulatory systolic blood pressure over 24 hours
• Change in serum low density lipoprotein cholesterol (LDL-C )

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171093

Study ID Number: CVAS489A2316

ClinicalTrials.gov Identifier: NCT00171093

Health Authority: United States: Food and Drug Administration