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

NCT ID: NCT00285181

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Simvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI between 18.0 and 25.00

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Principal Investigators

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Pierre PETIT, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique

Locations

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Centre d'Investigation Clinique

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF7808

Identifier Type: -

Identifier Source: org_study_id