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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: Clinical Trial Phase 4 study, sponsored by Rockefeller University.
NCT00850460 is a Phase 4 study that was terminated before completion, run by Rockefeller University. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).
Interventions
- DRUG Placebo
- DRUG Statins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
Why NCT00850460 stopped before completion
NCT00850460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00850460 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00850460's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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