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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

January 16, 2008
January 4, 2013
January 2008
July 2009   (final data collection date for primary outcome measure)
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.
Proportion (%) of patients achieving > or = 5% weight reduction at Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00603902 on ClinicalTrials.gov Archive Site
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.
  • Change in body weight (kg) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in waist and hip measurements from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in blood pressure (systolic and diastolic) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in Quality of Life measures from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • 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
  • Drug: Lorcaserin 10 mg BID
    Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
    Other Name: APD356
  • Drug: Matching Placebo
    Matching placebo tablet each morning and evening for a duration of 52 weeks.
  • Experimental: Lorcaserin 10 mg QD
    Lorcaserin 10 mg tablet each morning and placebo tablet each evening
    Intervention: Drug: Lorcaserin 10 mg QD
  • Experimental: Lorcaserin 10 mg BID
    Lorcaserin 10 mg tablet each morning and evening
    Intervention: Drug: Lorcaserin 10 mg BID
  • Placebo Comparator: Matching Placebo
    Matching placebo tablet each morning and evening
    Intervention: Drug: Matching Placebo
Fidler MC, Sanchez M, Raether B, Weissman NJ, Smith SR, Shanahan WR, Anderson CM; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011 Oct;96(10):3067-77. Epub 2011 Jul 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4008
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603902
APD356-011
No
Arena Pharmaceuticals
Arena Pharmaceuticals
Not Provided
Study Director: William Shanahan, MD Arena Pharmaceuticals
Principal Investigator: Steven Smith, MD Pennington Biomedical Research Center
Arena Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP