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OpenTrials
Completed

NCT Number: NCT00138528

Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Nuremberg, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • Male and female patients, aged between 18 and 75 years
  • Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)

Exclusion criteria

  • History of heart failure
  • HIV positive
  • Stroke

Other protocol defined inclusion and exclusion criteria may apply.

Treatment and study plan

Fluvastatin

Drug

Primary outcomes

  1. Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks

Secondary outcomes

  1. Change from baseline in low density lipoprotein cholesterol after 5 weeks

  2. Change from baseline in non high density lipoprotein cholesterol after 5 weeks

  3. Change from baseline in total cholesterol after 5 weeks

  4. Change from baseline in high density lipoprotein cholesterol after 5 weeks

  5. Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 30, 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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