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
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: January 2006
Intervention(s) in this Clinical Trial
- Drug: valsartan + simvastatin
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171093
