A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

Phase 2 Completed 1395 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.

Timeline

Start: 2011-03-31
Primary completion: 2012-10-22
Completion: 2013-10-10

Outcome

Met primary endpoint

registry Part 1: Placebo vs Part 1: Vibegron 50 mg; p = 0.007; Difference in LS means -0.64 (95% CI -1.11 to -0.18) NCT01314872 ↗

registry Part 1: Placebo vs Part 1: Vibegron 100 mg; p < 0.001; Difference in LS means -0.91 (95% CI -1.37 to -0.44) NCT01314872 ↗

paper From baseline to week 8, V50 and V100 significantly decreased average daily micturitions PMID 30661513 ↗

Publications

Results Mitcheson HD, Samanta S, Muldowney K, Pinto CA, Rocha BA, Green S, Bennett N, Mudd PN Jr, Frenkl TL. Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or Concomitantly with Tolterodine in Patients with an Overactive Bladder: A Multicenter, Phase IIb, Randomized, Double-blind, Controlled Trial. Eur Urol. 2019 Feb;75(2):274-282. doi: 10.1016/j.eururo.2018.10.006. Epub 2018 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolterodine	Unknown	4 mg	Oral
Subject	Vibegron	Unknown	3 mg	Oral
Subject	Vibegron	Unknown	15 mg	Oral
Subject	Vibegron	Unknown	50 mg	Oral
Subject	Vibegron	Unknown	100 mg	Oral