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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: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00400439 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00400439 record still lists
NCT00400439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00400439 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400439's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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