Status:
COMPLETED
The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Pharma Nord
Conditions:
Statin Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether supplements of Q10 and Selen are effective in reducing muscular adverse events (AE) in statin therapy.
Detailed Description
Statins inhibit the synthesis of cholesterol by inhibiting the enzyme HMG-CoA reductase. The reduction of intracellular cholesterol leads to an increase in the number of LDL-receptors, and subsequent ...
Eligibility Criteria
Inclusion
- Men and women 18 - 75 years old
- Indication for statin
- Previous history of muscular AE on statin therapy.
Exclusion
- If female, be of non-childbearing potential, i.e., post-menopausal (defined as \>12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential.
- Previously serious muscular AE
- Patients taking drugs interacting with statins, and where these drugs cannot be stopped.
- Allergy against selen
- Liver or kidney failure
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00113477
Start Date
May 1 2005
End Date
December 1 2007
Last Update
July 1 2011
Active Locations (1)
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1
Lipidklinikken, Rikshospitalet
Oslo, Oslo County, Norway, 0027