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BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

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ClinicalTrials.gov Identifier: NCT00603902
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Lorcaserin 10 mg QD Drug: Lorcaserin 10 mg BID Drug: Matching Placebo Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Primary Completion Date : July 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Drug: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Other Name: APD356
Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Other Name: APD356
Placebo Comparator: Matching Placebo
Matching placebo tablet each morning and evening
Drug: Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ]

    The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

    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.



Secondary Outcome Measures :
  1. Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ]
    The % change in body weight (kg) from baseline to week 52.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603902


Locations
United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Study Director: William Shanahan, MD Arena Pharmaceuticals
Principal Investigator: Steven Smith, MD Pennington Biomedical Research Center
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603902     History of Changes
Other Study ID Numbers: APD356-011
First Posted: January 29, 2008    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: January 2013

Keywords provided by Arena Pharmaceuticals:
Obesity
Weight loss
lorcaserin
APD356
BLOSSOM
Hypertension
Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms