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NCT00400439 · ClinicalTrials.gov registry record · Phase 2
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT00400439 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 77 participants.
The verdict
NCT00400439, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
Interventions
- DRUG placebo
- DRUG dalcetrapib (RO4607381)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400439
The ClinicalTrials.gov registry entry for NCT00400439 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00400439 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00400439 about?
NCT00400439 is a clinical study titled "A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381". This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were ori...
What is the current status of trial NCT00400439?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2007-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00400439?
The interventions under investigation include: placebo (DRUG), dalcetrapib (RO4607381) (DRUG).
Who is sponsoring clinical trial NCT00400439?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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