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NCT00395135 · ClinicalTrials.gov registry record · Phase 3
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,182
- Enrollment target
NCT00395135: Completed Phase 3 study, sponsored by Eisai.
NCT00395135 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 3,182 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (312% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00395135, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,182 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)
Primary Outcome
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Interventions
- DRUG Lorcaserin 10 mg BID
- DRUG Matching Placebo BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,182 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00395135 record still lists
NCT00395135 is an interventional study that assigns participants to a tested intervention. Its 3,182 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (312% higher).
The record links to 0 conditions, and to 2 interventions - of which Lorcaserin 10 mg BID is the first listed.
NCT00395135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00395135 about?
NCT00395135 is a clinical study titled "BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management". The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)
What is the current status of trial NCT00395135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,182 participants. The study started on 2006-11. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00395135?
The interventions under investigation include: Lorcaserin 10 mg BID (DRUG), Matching Placebo BID (DRUG).
Who is sponsoring clinical trial NCT00395135?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00395135's enrollment target sits among peer trials
3,182 74th of 2000 higher than 1,927 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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