Clinical Trial Details
| Trial ID: | L6798 |
| Source ID: | NCT00553787 |
| Associated Drug: | Vi-0521 |
| Title: | Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00553787/results |
| Conditions: | Obesity|Type 2 Diabetes |
| Interventions: | DRUG: VI-0521|DRUG: VI-0521|DRUG: VI-0521 |
| Outcome Measures: | Primary: Percent Weight Loss From Baseline to Week 56, Baseline to 56 weeks|Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF, Baseline to 56 weeks | |
| Sponsor/Collaborators: | Sponsor: VIVUS LLC | Collaborators: Medpace, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 2487 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-11 |
| Completion Date: | 2009-06 |
| Results First Posted: | 2012-09-06 |
| Last Update Posted: | 2012-09-10 |
| Locations: | Research Site, Birmingham, Alabama, 35294, United States|Research Site, Ridgefield, Connecticut, 06877, United States|Research Site, New York, New York, 10025, United States|Research Site, Durham, North Carolina, 27710, United States|Research Site, Toledo, Ohio, 43623, United States|Research Site, Austin, Texas, 78731, United States |
| URL: | https://clinicaltrials.gov/show/NCT00553787 |

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