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NCT00850460 · ClinicalTrials.gov registry record · Phase 4
Quality of Life in Patients With Statin-Associated Myopathy
A Phase 4 study, sponsored by Rockefeller University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT00850460 is a Phase 4 study that was terminated before completion, run by Rockefeller University. The registered enrollment target is 14 participants.
The verdict
NCT00850460, a Phase 4 study, was terminated before completion, sponsored by Rockefeller University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life. This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show: 1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point) 2. alleviation of muscle symptoms, 3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results 4. decreased intramyocellular lipid (IMCL) 5. improved insulin sensitivity.
Interventions
- DRUG Placebo
- DRUG Statins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00850460
The ClinicalTrials.gov registry entry for NCT00850460 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00850460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00850460 about?
NCT00850460 is a clinical study titled "Quality of Life in Patients With Statin-Associated Myopathy". The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscl...
What is the current status of trial NCT00850460?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2009-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00850460?
The interventions under investigation include: Placebo (DRUG), Statins (DRUG).
Who is sponsoring clinical trial NCT00850460?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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