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Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications) (COSMIC)

Primary Purpose

Statin Induced Myalgia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Coenzyme Q 10
Placebo control
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Statin Induced Myalgia focused on measuring Coenzyme Q 10, Statin, Myalgia

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms

Exclusion Criteria:

  • Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.

Sites / Locations

  • Hadassah-Hebrew University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

PO Placebo QD

PO Coenzyme Q 10 QD

Outcomes

Primary Outcome Measures

1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2008
Last Updated
January 24, 2013
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00716612
Brief Title
Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)
Acronym
COSMIC
Official Title
Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Statin Induced Myalgia
Keywords
Coenzyme Q 10, Statin, Myalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
PO Placebo QD
Arm Title
1
Arm Type
Experimental
Arm Description
PO Coenzyme Q 10 QD
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q 10
Other Intervention Name(s)
ubiquinone
Intervention Description
PO Coenzyme Q 10 120 mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
po Placebo QD
Primary Outcome Measure Information:
Title
1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score.
Time Frame
4, 8, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms Exclusion Criteria: Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rott, MD
Organizational Affiliation
Hadassah-Hebrew University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel

12. IPD Sharing Statement

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Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)

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