Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.

This study has been completed.
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
First received: January 31, 2006
Last updated: August 8, 2007
Last verified: August 2007
To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.

Condition Intervention
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.

Resource links provided by NLM:

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Blood antioxidant status before treatment and after treatment.
  • Lipid and protein peroxidation indexes before treatment and after treatment.
  • In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.

Secondary Outcome Measures:
  • Blood lipids before treatment and after treatment
  • LDL composition before and after treatment

Estimated Enrollment: 24
Study Start Date: November 2005
Study Completion Date: April 2007
Detailed Description:
Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile, exercice test, end of treatment

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI between 18.0 and 25.00

Exclusion Criteria:

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00285181

Centre d'Investigation Clinique
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Pierre PETIT, MD-PhD Centre d'Investigation Clinique
  More Information

ClinicalTrials.gov Identifier: NCT00285181     History of Changes
Other Study ID Numbers: UF7808 
Study First Received: January 31, 2006
Last Updated: August 8, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 26, 2016