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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.

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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

FieldValue
Enrollment Target 162 participants
Start Date 2009-02
Est. Completion 2015-11-30
Phase Phase 2

Sponsor

Columbia University

958 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.