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OpenTrials
Completed

NCT Number: NCT00171327

Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Arterial hypertension
  • Dyslipidemia
  • Cholesterol lowering diet

Exclusion criteria

  • Constant antihypertensive treatment
  • Diabetes mellitus
  • Myocardial infarction or stroke in the previous 3 months

Other inclusion and exclusion criteria may apply

Treatment and study plan

valsartan, fluvastatin

Drug

Primary outcomes

  1. Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks

  2. Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks

Secondary outcomes

  1. Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides

  2. Evaluating blood pressure effect on endothelial function

  3. Evaluating total cholesterol effect on endothelial function

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Efficacy and Safety of Fluvastatin 80 mg or Valsartan 160 mg and Their Combination in Dyslipidemic Patients With Arterial Hypertension and Endothelial Dysfunction

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Nov 8, 2011

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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