Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)

Summary

The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Timeline

Start

2008-06-09

Primary completion

2009-01-30

Completion

2009-01-30

Outcome

Missed primary endpoint

registry analysis (superiority or other test); SCH 497079 vs Placebo; p = 0.187; Difference in means 0.41 (95% CI -0.20 to 1.03); ANOVA NCT00642993 ↗

Drugs

Indications