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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285181
First Posted: February 1, 2006
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Montpellier
  Purpose
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
Healthy Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18.0 and 25.00

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285181


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

ClinicalTrials.gov Identifier: NCT00285181     History of Changes
Other Study ID Numbers: UF7808
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: August 9, 2007
Last Verified: August 2007

Keywords provided by University Hospital, Montpellier:
persons

Additional relevant MeSH terms:
Simvastatin
Antioxidants
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protective Agents
Physiological Effects of Drugs