Does Coenzyme Q 10 Supplementation Reduces Muscle Pain Caused by Statins? (Cholesterol Lowering Medications) - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, July 2008

First Received: July 14, 2008 Last Updated: August 11, 2008 History of Changes

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00716612

Purpose

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.

Condition	Intervention
Statin Induced Myalgia	Drug: Coenzyme Q 10 Drug: Placebo control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Statins

Drug Information available for: Coenzyme Q10

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

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. [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of patients with CPK elevation. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator PO Placebo QD	Drug: Placebo control po Placebo QD
1: Experimental PO Coenzyme Q 10 QD	Drug: Coenzyme Q 10 PO Coenzyme Q 10 100mg QD

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716612

Locations

Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91240

Sponsors and Collaborators

Hadassah Medical Organization

More Information

No publications provided

Responsible Party:	Hadassah-Hebrew University Medical Center ( David Rott )
Study ID Numbers:	Solgar-080
Study First Received:	July 14, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00716612 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Coenzyme Q 10
Statin
Myalgia

Study placed in the following topic categories:

Antimetabolites
Antilipemic Agents
Vitamins
Ubiquinone
Trace Elements

Pain
Anticholesteremic Agents
Micronutrients
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coenzyme Q10

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coenzyme Q10
Therapeutic Uses
Vitamins
Ubiquinone
Micronutrients

ClinicalTrials.gov processed this record on September 10, 2009