Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT00395135
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2006-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management; A 104-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: