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CompletedNCT00285181Updated Aug 9, 2007

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

An interventional study of Simvastatin in Healthy, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-08-09.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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.

Read the 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

02

Conditions studied

  • Healthy

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Keywords

  • persons
03

In context

Muscular Diseases

280 studies on the registry are indexed under Muscular Diseases; 63 are open to participants now.

This study's planned enrollment of 24 is below the median of 34 across 157 interventional studies indexed under Muscular Diseases.

Browse Muscular Diseases studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI between 18.0 and 25.00

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants (estimated)

Interventions

  • DrugSimvastatin
06

What researchers measure

Primary outcomes

  1. Blood antioxidant status before treatment and after treatment.

  2. Lipid and protein peroxidation indexes before treatment and after treatment.

  3. In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.

Secondary outcomes

  1. Blood lipids before treatment and after treatment

  2. LDL composition before and after treatment

07

Study locations

1 site
  • Centre d'Investigation Clinique
    Montpellier, 34295, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00285181
Lead sponsor
University Hospital, Montpellier
First posted
Feb 1, 2006
Start date
Nov 2005
Completion
Apr 2007
Last update
Aug 9, 2007

Study contacts

Pierre PETIT, MD-PhD
principal investigator · Centre d'Investigation Clinique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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