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Sponsored by: |
Arena Pharmaceuticals |
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Information provided by: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00829140 |
The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: Placebo Drug: Lorcaserin 10mg BID |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A 56-Day , Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake in Overweight and Obese Patients (TULIP) |
Estimated Enrollment: | 56 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo BID: Placebo Comparator | Drug: Placebo |
Lorcaserin 10mg BID: Experimental | Drug: Lorcaserin 10mg BID |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of any of the following cardiovascular conditions:
Contact: Scott C Stubbe | 858-453-7200 ext 1602 | sstubbe@arenapharm.com |
Contact: Marianne Mancini | 858-453-7200 ext 1678 | mmancini@arenapharm.com |
United States, Louisiana | |
Pennington Biomedical Research Center | Recruiting |
Baton Rouge, Louisiana, United States, 70808 | |
Contact: Eric Ravussin, PhD 225-763-3186 Eric.Ravussin@pbrc.edu | |
Contact: Steven R Smith, MD 225.763.3028 SmithSR@pbrc.edu | |
Principal Investigator: Eric Ravussin, PhD |
Principal Investigator: | Eric Ravussin, PhD | Pennington Biomedical Research Center |
Responsible Party: | Arena Pharmaceuticals, Inc. ( Christen Anderson MD, PhD ) |
Study ID Numbers: | APD356-014 |
Study First Received: | January 22, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00829140 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |