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NCT01976936 · ClinicalTrials.gov registry record · Phase 2
Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT01976936 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 162 participants.
The verdict
NCT01976936, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
Study Summary
This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory markers and lipid levels will also be assessed.
Interventions
- OTHER Placebo
- DRUG Low Dose Lovastatin
- DRUG High Dose Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2009-02 |
| Est. Completion | 2015-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01976936
The ClinicalTrials.gov registry entry for NCT01976936 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01976936 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01976936 about?
NCT01976936 is a clinical study titled "Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2". This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be...
What is the current status of trial NCT01976936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2009-02. Estimated completion is 2015-11-30.
What interventions are being tested in trial NCT01976936?
The interventions under investigation include: Placebo (OTHER), Low Dose Lovastatin (DRUG), High Dose Lovastatin (DRUG).
Who is sponsoring clinical trial NCT01976936?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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