A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

Summary

The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.

Timeline

Start

2008-08

Primary completion

2009-09

Completion

2009-12

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Placebo: -16.6 (Standard Error 4.15) events/hour LEAST_SQUARES_MEAN Top Dose: -31.46 (Standard Error 4.25) events/hour NCT00745251 ↗

registry analysis (superiority or other test); Placebo vs Top Dose; p = 0.0084; Mean Difference (Final Values) -14.86; ANCOVA NCT00745251 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentermine	Small molecule	15 mg	—
Subject	Topiramate	Small molecule	92 mg	—

Indications