- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285181
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
August 8, 2007 updated by: University Hospital, Montpellier
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.
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.
Study Overview
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
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Centre d'Investigation Clinique
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI between 18.0 and 25.00
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Blood lipids before treatment and after treatment
|
LDL composition before and after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: PIERRE PETIT, MD-PhD, Centre d'Investigation Clinique
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
January 31, 2006
First Posted (Estimate)
February 1, 2006
Study Record Updates
Last Update Posted (Estimate)
August 9, 2007
Last Update Submitted That Met QC Criteria
August 8, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF7808
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Simvastatin
-
University of CopenhagenCompletedCardiovascular Disease | Diabetes MellitusDenmark
-
Organon and CoCompletedMyocardial Infarction | Hypercholesterolemia
-
dr.Frank L.J. VisserenMerck Sharp & Dohme LLCCompletedThe PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study (PANACEA)Metabolic SyndromeNetherlands, Spain
-
University of Sao PauloCompletedCoronary Heart Disease
-
University of Maryland, BaltimoreMerck Sharp & Dohme LLCCompletedMetabolic SyndromeUnited States
-
Peking Union Medical College HospitalUnknownAtherosclerosisChina
-
Organon and CoCompletedHypercholesterolemia
-
Hue University of Medicine and PharmacyUniversità degli Studi di SassariUnknownChronic Kidney Diseases | HypercholesterolemiaVietnam
-
Federal State Budgetary Scientific Institution,...Completed
-
Organon and CoCompleted