|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00590408 |
|
Date of registration:
|
28/12/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
March 2006 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00590408 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robyn Kondrack, PharmD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Creighton University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients who are taking statins and develop unexplained, persistent myalgia with a
normal plasma creatinine kinase level
Exclusion Criteria:
- Women of childbearing potential
- Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
- Patients receiving concomitant niacin, fibric acid derivatives, bile acid
sequestrants, or other drugs that effect cholesterol levels or interact with statins
- Patients with a history of alcoholism or malnutrition
- Patients who have had acute coronary syndrome or muscle trauma in the prior 7
days
- Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative
disk disease.
Age minimum:
19 Years
Age maximum:
79 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Statin-associated Myalgia
|
|
Intervention(s)
|
|
Dietary Supplement: coenzyme Q10
|
|
Dietary Supplement: matching placebo
|
|
Primary Outcome(s)
|
|
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
[Time Frame: every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks]
|
|
Secondary Outcome(s)
|
|
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
[Time Frame: every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|