BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | January 2008 |
| End Date: | August 2009 |
A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the
end of 1 year of treatment in overweight and obese patients.
end of 1 year of treatment in overweight and obese patients.
Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of
lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and
female volunteers aged 18 to 65 years inclusive.
lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and
female volunteers aged 18 to 65 years inclusive.
Inclusion Criteria:
- Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with
or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose
intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
- Ability to complete a 1 year study
Exclusion Criteria:
- Pregnancy
- Diabetes mellitus (type I, II or other)
- History of symptomatic heart valve disease
- Serious or unstable current or past medical conditions
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