drugset / Trial / NCT00577720

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

NCT00577720 ↗

Phase 2 Completed 181 enrolled Warner Chilcott
RandomizedParallel-groupDouble-blindTreatment

Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Timeline

Start
2006-07
Primary completion
2007-01
Completion
2007-01

Outcome

Met primary endpoint

registry Ratio (LS Mean 35 mg DRFB/35 mg IRBB) 1.437 (90% CI 1.091 to 1.964) NCT00577720 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Risedronate Small molecule 35 mg Oral
Subject Risedronate Small molecule 50 mg Oral

Indications

No indication recorded.