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NCT00590408 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
A Phase 4 study, sponsored by Creighton University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT00590408 is a Phase 4 study that was terminated before completion, run by Creighton University. The registered enrollment target is 10 participants.
The verdict
NCT00590408, a Phase 4 study, was terminated before completion, sponsored by Creighton University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (\<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.
Interventions
- DIETARY_SUPPLEMENT coenzyme Q10
- DIETARY_SUPPLEMENT matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590408
The ClinicalTrials.gov registry entry for NCT00590408 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Creighton University, which has 98 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which coenzyme Q10 is the first listed.
NCT00590408 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590408 about?
NCT00590408 is a clinical study titled "Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia". Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (\<0.01%; less than one in 10,000 pe...
What is the current status of trial NCT00590408?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2006-03. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00590408?
The interventions under investigation include: coenzyme Q10 (DIETARY_SUPPLEMENT), matching placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00590408?
This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.
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