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

Phase 1

• Conditions: Overactive Bladder; MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857

• Registration Number: EUCTR2011-002533-18-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-30
• Study Completion: 2013-10-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1395

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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