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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vibegron
Tolterodine ER
Placebo matching vibegron
Placebo matching tolterodine ER
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Overactive bladder, MK-4618, tolterodine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study
  • Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria
  • Is able to read, understand and complete questionnaires and voiding diaries without assistance
  • Is ambulatory and in good general physical and mental health
  • No clinically significant electrocardiogram or laboratory abnormality

Exclusion Criteria:

  • If female, is currently pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
  • Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia
  • Allergy, intolerance, or history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or vibegron (MK-4618) formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label
  • Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence
  • History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply
  • History of continual urine leakage
  • Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months
  • Known history of elevated postvoid residual
  • Bladder training or electrostimulation within 2 weeks or is planning to initiate either procedure during the study
  • Active or recurrent (>6 episodes per year) urinary tract infections
  • Current hematuria
  • Required use of an indwelling catheter or requires intermittent catheterization
  • History of fecal incontinence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Experimental

    Placebo Comparator

    Experimental

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1: placebo

    Part 1: vibegron 3 mg

    Part 1: vibegron 15 mg

    Part 1: vibegron 50 mg

    Part 1: vibegron 100 mg

    Part 1: tolterodine ER 4 mg

    Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg

    Part 2: placebo

    Part 2: vibegron 100 mg

    Part 2: tolterodine ER 4 mg

    Part 2: vibegron 100 mg + tolterodine ER 4 mg

    Extension Study: vibegron 50 mg

    Extension Study: vibegron 100 mg

    Extension Study: tolterodine ER 4 mg

    Extension Study: vibegron 100 mg + tolterodine ER 4 mg

    Arm Description

    Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.

    Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.

    Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.

    Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.

    Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.

    Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.

    Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.

    Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.

    Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.

    Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.

    Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.

    Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.

    Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.

    Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.

    Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.

    Outcomes

    Primary Outcome Measures

    Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8
    Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.
    Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Extension Study: Number of Participants Who Experienced an Adverse Event (AE)
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

    Secondary Outcome Measures

    Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8
    Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Extension Study: Change From Baseline in Average Daily Micturitions at Week 52
    Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52
    Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52
    Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

    Full Information

    First Posted
    March 11, 2011
    Last Updated
    January 16, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01314872
    Brief Title
    A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 31, 2011 (Actual)
    Primary Completion Date
    October 22, 2012 (Actual)
    Study Completion Date
    October 10, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Bladder, Overactive
    Keywords
    Overactive bladder, MK-4618, tolterodine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1395 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: vibegron 3 mg
    Arm Type
    Experimental
    Arm Description
    Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: vibegron 15 mg
    Arm Type
    Experimental
    Arm Description
    Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: vibegron 50 mg
    Arm Type
    Experimental
    Arm Description
    Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: vibegron 100 mg
    Arm Type
    Experimental
    Arm Description
    Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: tolterodine ER 4 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
    Arm Title
    Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
    Arm Type
    Experimental
    Arm Description
    Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
    Arm Title
    Part 2: placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
    Arm Title
    Part 2: vibegron 100 mg
    Arm Type
    Experimental
    Arm Description
    Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
    Arm Title
    Part 2: tolterodine ER 4 mg
    Arm Type
    Active Comparator
    Arm Description
    Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
    Arm Title
    Part 2: vibegron 100 mg + tolterodine ER 4 mg
    Arm Type
    Experimental
    Arm Description
    Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
    Arm Title
    Extension Study: vibegron 50 mg
    Arm Type
    Experimental
    Arm Description
    Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
    Arm Title
    Extension Study: vibegron 100 mg
    Arm Type
    Experimental
    Arm Description
    Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
    Arm Title
    Extension Study: tolterodine ER 4 mg
    Arm Type
    Experimental
    Arm Description
    Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
    Arm Title
    Extension Study: vibegron 100 mg + tolterodine ER 4 mg
    Arm Type
    Experimental
    Arm Description
    Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Vibegron
    Other Intervention Name(s)
    MK-4618
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tolterodine ER
    Other Intervention Name(s)
    Detrol®
    Intervention Description
    Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo matching vibegron
    Intervention Description
    Participants received placebo matching vibegron tablets, taken orally each morning.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo matching tolterodine ER
    Intervention Description
    Participants received placebo matching tolterodine ER capsule, taken orally each morning.
    Primary Outcome Measure Information:
    Title
    Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.
    Time Frame
    Baseline and Week 8
    Title
    Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.
    Title
    Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Part 1: up to 8 weeks; Part 2: up to 4 weeks
    Title
    Extension Study: Number of Participants Who Experienced an Adverse Event (AE)
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Extension: up to 54 weeks (including 2-week follow-up)
    Title
    Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
    Description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
    Time Frame
    Extension: up to 52 weeks
    Secondary Outcome Measure Information:
    Title
    Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Time Frame
    Baseline and Week 8
    Title
    Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Time Frame
    Baseline and Week 8
    Title
    Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.
    Time Frame
    Baseline and Week 8
    Title
    Extension Study: Change From Baseline in Average Daily Micturitions at Week 52
    Description
    Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Time Frame
    Baseline and Week 52 of Extension Study
    Title
    Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Time Frame
    Baseline and Week 52 of Extension Study
    Title
    Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Time Frame
    Baseline and Week 52 of Extension Study
    Title
    Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52
    Description
    Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.
    Time Frame
    Baseline and Week 52 of Extension Study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria Is able to read, understand and complete questionnaires and voiding diaries without assistance Is ambulatory and in good general physical and mental health No clinically significant electrocardiogram or laboratory abnormality Exclusion Criteria: If female, is currently pregnant or breast-feeding, or expecting to conceive within the projected duration of the study Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia Allergy, intolerance, or history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or vibegron (MK-4618) formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply History of continual urine leakage Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months Known history of elevated postvoid residual Bladder training or electrostimulation within 2 weeks or is planning to initiate either procedure during the study Active or recurrent (>6 episodes per year) urinary tract infections Current hematuria Required use of an indwelling catheter or requires intermittent catheterization History of fecal incontinence
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    30661513
    Citation
    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.
    Results Reference
    result

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

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