Overactive Bladder MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Interventions
Product Name: MK-4618 3 mg
Product Code: MK-4618
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 3. A female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as: onoe who has either 1) reached natural manopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by laboratoy, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomy with pr without hysterectomy, 3) bilateral tubal ligation or 4) hysterectomy. 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
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. 5. Patient is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety and Tolerability ;Timepoint(s) of evaluation of this end point: Week 52; Main Objective: 1. To assess the long-term safety and tolerability of treatment with MK-4618 compared to tolterodine ER. 2. To assess the long-term safety profile of MK-4618 dosed concomitantly with 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 52 weeks of treatment in terms of: the average number of daily micturitions in all patients with OAB the average number of urge incontinence episodes in patients with OAB wet the average number of total incontinence episodes in patients with OAB wet the average number of strong urge episodes in all patients with OAB | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in average number of daily micturitions Change from baseline in average number of daily urge incontinence episodes Change from baseline in average number of daily total incontinence episodes Change from baseline in average number of daily strong urge episodes ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Australia, Austria, Canada, Denmark, Germany, Italy, Japan, Korea, Democratic People's Republic of, Mexico, New Zealand, Norway, Peru, Poland, Russian Federation, South Africa, Sweden, United Kingdom, United States
Contacts
Public ContactDeborah Gurner
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed