A Study of the Efficacy and Safety of MK-4618 in Patients with OveractiveBladder (OAB)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

Patient must meet ALL of the following criteria before entering the 52-week extension.
Visit 1 Inclusion Criteria
1. Patient completed either Part 1 or Part 2 of Protocol 008.
2. Patient is able to understand study procedures and agrees to participate in the
extension study by giving written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

Patient MUST be excluded if he/she meets ANY of the following exclusion criteria.
Visit 1 Exclusion Criteria
1. Patient had any serious, drug-related, or unresolved clinical or laboratory adverse
experiences during participation in Protocol 008 that in the Investigator’s medical
judgment would preclude the patient from participation in, or completion of, the
extension study.
2. Patient meets any of the criteria for discontinuation in MK-4618 Protocol 008,
including requirement of therapy with medication listed in Appendix 6.3 (CYP3A4
inducers/inhibitors and Pgp inhibitors).
3. Patient has clinically significant changes in his/her general medical condition since
enrolling in Protocol 008 that in the Investigator’s medical judgment would preclude
the patient from participating in, or completing, the study.
4. Patient has been off base study drug for > 14 days at Visit 1.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To assess the long-term safety and tolerability of treatment with MK-4618 compared<br>to tolterodine ER.<br>2. To assess the long-term safety profile of MK-4618 dosed concomitantly with<br>tolterodine ER, relative to MK-4618 monotherapy and/or tolterodine ER monotherapy.;Secondary Objective: 1. To assess the efficacy profile of MK-4618 compared with tolterodine ER after<br>52 weeks of treatment in terms of:<br>the average number of daily micturitions in all patients with OAB<br>the average number of urge incontinence episodes in patients with OAB wet<br>the average number of total incontinence episodes in patients with OAB wet<br>the average number of strong urge episodes in all patients with OAB;Primary end point(s): Safety and Tolerability ;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline in average number of daily micturitions<br>Change from baseline in average number of daily urge incontinence episodes<br>Change from baseline in average number of daily total incontinence episodes<br>Change from baseline in average number of daily strong urge episodes;Timepoint(s) of evaluation of this end point: Week 52

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