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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 study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171093
First received: September 10, 2005
Last updated: September 19, 2008
Last verified: September 2008

September 10, 2005
September 19, 2008
September 2004
January 2006   (final data collection date for primary outcome measure)
  • Change in average ambulatory systolic blood pressure over 24 hours
  • Change in serum low density lipoprotein cholesterol (LDL-C )
Not Provided
Complete list of historical versions of study NCT00171093 on ClinicalTrials.gov Archive Site
  • 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
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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
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..

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hypertension
  • Hypercholesterolemia
Drug: valsartan + simvastatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
369
Not Provided
January 2006   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00171093
CVAS489A2316
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Novartis
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP