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BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603902
First received: January 16, 2008
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Drug: Lorcaserin 10 mg QD
Drug: Lorcaserin 10 mg BID
Drug: Matching Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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:
  • Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The % change in body weight (kg) from baseline to week 52.


Enrollment: 4008
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Arena Pharmaceuticals, Inc. Home Page  This link exits the ClinicalTrials.gov site

No publications provided by Arena Pharmaceuticals

Additional 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
Study First Received: January 16, 2008
Results First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013