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OpenTrials
Completed

NCT Number: NCT00125125

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Dyslipidemia
  • History of Myalgia

Exclusion criteria

  • Previous treatment with fluvastatin
  • Age < 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Fluvastatin

Drug

Primary outcomes

  1. Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary outcomes

  1. Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation

  2. Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks

  3. Number of patients who reach target LDL after 12 weeks

  4. Change from baseline in marker of inflammation after 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jul 29, 2005
Registry last updated
May 17, 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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