NCT01314872

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

A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder A 52-week Extension to: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,395 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All participants received placebo (run-in) for 1 week prior to randomization to Parts 1 and 2. Participants who complete the base study may be screened for a year-long, multicenter extension for assessment of long-term safety and efficacy.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Vibegron	Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.
DRUG	Tolterodine ER	Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
DRUG	Placebo matching vibegron	Participants received placebo matching vibegron tablets, taken orally each morning.
DRUG	Placebo matching tolterodine ER	Participants received placebo matching tolterodine ER capsule, taken orally each morning.

Timeline

• Start date: 2011-03-31
• Primary completion: 2012-10-22
• Completion: 2013-10-10
• First posted: 2011-03-15
• Last updated: 2019-02-04
• Results posted: 2016-06-17