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NCT01126697 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies
A Phase 2 study, sponsored by Cooperative International Neuromuscular Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01126697 is a Phase 2 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 63 participants.
The verdict
NCT01126697, a Phase 2 study, has completed, sponsored by Cooperative International Neuromuscular Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10 alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication. Randomization will be stratified by ambulatory status and corticosteroid use. The primary outcome for the study is the myocardial performance index (MPI), measured by standard Doppler echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and 24. Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will be offered participation in a companion protocol: PITT1215 A Natural History Companion Study to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac dysfunction in these disorders.This will be an 18-month longitudinal natural history study designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies.
Interventions
- DRUG Coenzyme Q10 and Lisinopril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2010-02 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01126697
The ClinicalTrials.gov registry entry for NCT01126697 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cooperative International Neuromuscular Research Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Coenzyme Q10 and Lisinopril is the first listed.
NCT01126697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01126697 about?
NCT01126697 is a clinical study titled "Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies". The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10 alone, Arm 2 Lisinopril alon...
What is the current status of trial NCT01126697?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2010-02. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01126697?
The interventions under investigation include: Coenzyme Q10 and Lisinopril (DRUG).
Who is sponsoring clinical trial NCT01126697?
This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
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