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NCT Number: NCT00171093

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..

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan + simvastatin

Drug

Primary outcomes

  1. Change in average ambulatory systolic blood pressure over 24 hours

  2. Change in serum low density lipoprotein cholesterol (LDL-C )

Secondary outcomes

  1. Adverse events and serious adverse events at each study visit for 42 days

  2. Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies

  3. Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime

  4. Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication

  5. Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 15, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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