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
Phase 3
Completed
- Conditions
- HYPERTENSIONHYPERCHOLESTEROLEMIA
- Registration Number
- NCT00171093
- Lead Sponsor
- Novartis
- 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 369
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in average ambulatory systolic blood pressure over 24 hours Change in serum low density lipoprotein cholesterol (LDL-C )
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸E. Hanover, New Jersey, United States