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NCT00353522 · ClinicalTrials.gov registry record · Phase 2
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT00353522: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00353522 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00353522, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG Placebo
- DRUG dalcetrapib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00353522 record still lists
NCT00353522 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00353522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00353522 about?
NCT00353522 is a clinical study titled "A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.". This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant...
What is the current status of trial NCT00353522?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2006-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00353522?
The interventions under investigation include: Placebo (DRUG), dalcetrapib (DRUG).
Who is sponsoring clinical trial NCT00353522?
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 NCT00353522's enrollment target sits among peer trials
135 532nd of 2000 higher than 1,464 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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