Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00716612
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2008-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D014451', 'term': 'Ubiquinone'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '4, 8, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coenzyme Q 10', 'Statin', 'Myalgia'], 'conditions': ['Statin Induced Myalgia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT00716612', 'acronym': 'COSMIC', 'briefTitle': 'Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors', 'orgStudyIdInfo': {'id': 'Solgar-080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'PO Placebo QD', 'interventionNames': ['Drug: Placebo control']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PO Coenzyme Q 10 QD', 'interventionNames': ['Drug: Coenzyme Q 10']}], 'interventions': [{'name': 'Coenzyme Q 10', 'type': 'DRUG', 'otherNames': ['ubiquinone'], 'description': 'PO Coenzyme Q 10 120 mg QD', 'armGroupLabels': ['1']}, {'name': 'Placebo control', 'type': 'DRUG', 'description': 'po Placebo QD', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91240', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah-Hebrew University Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'David Rott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah-Hebrew University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'David Rott', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}