- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026311
Coenzyme Q10 in Older Athletes Treated With Statin Medications
May 1, 2012 updated by: Richard Deichmann, MD
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
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
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Ochsner
-
-
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
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients ≥ 50 years of age, male or female.
- Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
Self-Described Athletes with any of the following characteristics:
- Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment
- Regular exercise activity of at least 45 minutes duration 5 times per week
Exclusion Criteria:
- Use of coenzyme Q10 during the preceding two months.
- CPK level at baseline greater than two times the upper limits of normal
- LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
- LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent
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: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
|
1 placebo q d during treatment period
|
ACTIVE_COMPARATOR: Coenzyme Q10
200mg of coenzyme Q10
|
200 mg of Coenzyme q 10
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population
Time Frame: The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.
|
The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Deichmann, MD, Ochsner
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, 2009
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (ESTIMATE)
December 4, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
May 3, 2012
Last Update Submitted That Met QC Criteria
May 1, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-076
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 Myalgia
-
Assiut UniversityCompleted
-
Assiut UniversityCompleted
-
Creighton UniversityTerminatedStatin-associated MyalgiaUnited States
-
Universidade Federal do Rio Grande do NorteCompletedMyalgia [C05.651.542]
-
Hadassah Medical OrganizationCompletedStatin Induced MyalgiaIsrael
-
Riphah International UniversityCompleted
-
Universidad Nacional Andres BelloCompletedMyalgia of Mastication MuscleChile
-
State University of New York at BuffaloCompletedAdult Females | Bilateral Masseter MyalgiaUnited States
-
Dr. Horst Schmidt Klinik GmbHCompletedIntubating Conditions | Performance With Respiratory Exercise Device | Postoperative MyalgiaGermany
-
Universidad Nacional Andres BelloCompletedMyalgia of Mastication Muscle
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States