BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management - Full Text View

Sponsor:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00603902

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 Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Obesity Weight Control

Drug Information available for: APD-356

U.S. FDA Resources

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

Proportion (%) of patients achieving > or = 5% weight reduction at Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	3000
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
1: Experimental lorcaserin 10 mg QD	Drug: lorcaserin lorcaserin 10 mg QD
2: Experimental lorcaserin 10 mg BID	Drug: lorcaserin lorcaserin 10 mg BID
3: Placebo Comparator placebo	Drug: placebo placebo

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
San Diego, California, United States, 92121

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Director:

Christen M Anderson, MD, PhD

Arena Pharmaceuticals

More Information

Additional Information:

Arena Pharmaceuticals, Inc. Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Arena Pharmaceuticals ( c/o: Vice President and Chief Medical Officer )
Study ID Numbers:	APD356-011
Study First Received:	January 16, 2008
Last Updated:	October 7, 2009
ClinicalTrials.gov Identifier:	NCT00603902 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:

lorcaserin
Obesity
Weight loss
APD356
BLOSSOM
Hypertension

Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on February 08, 2010