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Completed

NCT Number: NCT00254475

A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia

The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Elevated LDL-Cholesterol
  • Essential hypertension

Exclusion criteria

  • Severe Hypertension
  • Prior or known muscular or neuromuscular disease of any type
  • A history of cardiovascular disease
  • Hypertension or hypercholesterolemia due to secondary causes
  • Uncontrolled diabetes or insulin treatment
  • Evidence of hepatic or renal disease

Other protocol-defined exclusion criteria may apply

Treatment and study plan

simvastatin

Drug

valsartan

Drug

Primary outcomes

  1. Low density lipoproteins after 6 weeks

Secondary outcomes

  1. Lipid profile at 6, 12 wks

  2. BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks

  3. SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks

  4. Systolic and diastolic bp at 6, 12 wks

  5. Serious/adverse events, labs, physical exams, vitals up to 12 wks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 16, 2005
Registry last updated
Aug 19, 2014

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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