| Trial ID: | L2454 |
| Source ID: | NCT00603291
|
| Associated Drug: |
Lorcaserin 10 Mg Once Daily (Qd)
|
| Title: |
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00603291/results
|
| Conditions: |
Obesity
|
| Interventions: |
DRUG: Lorcaserin 10 mg once daily (QD)|DRUG: Lorcaserin 10 mg twice a day (BID)|DRUG: Matching Placebo
|
| Outcome Measures: |
Primary: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52, The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks., Baseline and Week 52 | Secondary: Percent Change in Body Weight From Baseline to Week 52, The percent change in body weight (kg) from baseline to week 52., Baseline and Week 52
|
| Sponsor/Collaborators: |
Sponsor: Eisai Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
604
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-12
|
| Completion Date: |
2010-10
|
| Results First Posted: |
2013-02-07
|
| Last Update Posted: |
2019-10-02
|
| Locations: |
Arena Pharmaceuticals, Inc., San Diego, California, 92121, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00603291
|
