At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
VI-0521 +3 moredrug
Likely dose
VI-0521 3.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.
In Brief
A Phase 2 clinical trial evaluating VI-0521, Placebo, and 2 other interventions for Overweight and Obesity. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesUnited States
CollaboratorsMDS Pharma Services
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedDec 10, 2008
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.6 years ago
Interventions
VI-0521drug
Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
Placebodrug
Placebo daily for 4 weeks
Alcoholother
alcohol placeboother
fruit juice