NCT00806260

A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	VI-0521	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
DRUG	Placebo	Placebo daily for 4 weeks
OTHER	Alcohol
OTHER	alcohol placebo	fruit juice

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-12-10
• Last updated: 2013-09-13
• Results posted: 2013-09-13

Locations

1 site across 1 country: United States