Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000545662
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coenzyme Q10 and tolerability of simvastatin in subjects with a history of statin-induced myalgia
Scientific title
Coenzyme Q10 and tolerability of simvastatin in subjects with a history of statin-induced myalgia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Statin-induced myalgia in subjects with hypercholesterolaemia 672 0
Condition category
Condition code
Diet and Nutrition 746 746 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: Fourty four participants will be enrolled in this randomised, placebo-controlled study. All 44 participants will have been unable to tolerate statin therapy due to myalgia, and will not be taking a full dose of statin at time of enrolment. All 44 participants will be initiated on simvastatin 10 mg/day for one month, then titrated to 20 mg/day for a further month, then titrated to 40 mg/day for a final month. In a randomised fashion, 22 of the participants will receive 200 mg/day coenzyme Q10, and the other twenty two will receive matching placebo. All participants will be free to either discontinue the study, or drop down the simvastatin dose to a tolerated level, if they experience significant myalgia. At the conclusion of the study, any participants experiencing myalgia and shown to be on placebo will be able to discuss coenzyme Q10 co-supplementation with statin therapy with the researchers.

At baseline, at the conclusion of each dose-titration step, or immediately after drop-out from the study, coenzyme Q10 concentration of plasma will be determined, creatine kinase and lactate/pyruvate ratio will be measured, and lipid profiles will be assessed. Myalgia will also be assessed at all visits, via completion of a visual analogue scale for myalgia. A baseline sample will be collected for mitochondrial (genetic) variation analysis.

Part 2: Forty-four age and sex-matched controls who have been shown to tolerate statin therapy and not experience myalgia will be selected, and samples will be collected and analysed for mitochondrial (genetic) variation. These results will be compared with the results of the mitochondrial variation screening of the 44 patients who have experienced myalgia on statin, in an effort to find a correlation between mitochondrial variation and myalgia.

Part 3: Baseline and 3-month coenzyme Q10 concentration of 44 samples from clinic patients who have not experienced myalgia on statin therapy, will be compared with the coenzyme Q10 concentration of the 44 (primary study) patients who have had myalgia. This study will address whether either the baseline coenzyme Q10 concentration, or subsequent changes in coenzyme Q10 correlate with myalgia.
Intervention code [1] 544 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 933 0
To investigate whether supplementation with coenzyme Q10 reduces or abolishes myalgic symptoms during statin therapy.
Timepoint [1] 933 0
Secondary outcome [1] 1783 0
To elucidate the mechanisms of statin-induced myalgia.
Timepoint [1] 1783 0
Secondary outcome [2] 1784 0
To test the hypothesis that inherited mitochondrial (genetic) variation occurs more frequently in those subjects with a history of statin-induced myalgia compared with those able to tolerate statins.
Timepoint [2] 1784 0

Eligibility
Key inclusion criteria
The patient has previously been unable to continue on a full dose of statin therapy due to side effects of myalgia.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are taking warfarin; patients who are unable to consent to being part of the trial; patients who are pregnant, patients who are taking vitamin or antioxidant supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Supplements and placebo are identical on visual inspection. Treatments are coded and only pharmacy knows which code has been allocated to which treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was via random numbers. Participants were stratified according to severity of previously experienced statin-induced myalgia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 211 0
New Zealand
State/province [1] 211 0

Funding & Sponsors
Funding source category [1] 827 0
Charities/Societies/Foundations
Name [1] 827 0
New Zealand Heart Foundation
Country [1] 827 0
New Zealand
Primary sponsor type
Hospital
Name
Lipid and Diabetes Research Group, Christchurch Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 695 0
Commercial sector/Industry
Name [1] 695 0
Canterbury Health Laboratories
Address [1] 695 0
Country [1] 695 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36046 0
Address 36046 0
Country 36046 0
Phone 36046 0
Fax 36046 0
Email 36046 0
Contact person for public queries
Name 9733 0
Dr. Chris Florkowski
Address 9733 0
Biochemistry Unit
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 9733 0
New Zealand
Phone 9733 0
+64 3 3649570
Fax 9733 0
Email 9733 0
[email protected]
Contact person for scientific queries
Name 661 0
Dr. Chris Florkowski
Address 661 0
Biochemistry Unit
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 661 0
New Zealand
Phone 661 0
+64 3 3649570
Fax 661 0
Email 661 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.