A Study of the Efficacy and Safety of Vibegron (MK-4618)... | NCT01314872 | Trialant
NCT01314872
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 4, 2019Actual
Enrollment
1,395Actual
Phase
Phase 2
Conditions
Urinary Bladder, Overactive
Interventions
Vibegron
Tolterodine ER
Placebo matching vibegron
Placebo matching tolterodine ER
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01314872
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
4618-008
Secondary IDs
ID
Type
Description
Link
132241
Registry Identifier
JAPIC-CTI
2010-022121-15
EudraCT Number
2011-002533-18
EudraCT Number
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
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 31, 2011Actual
Primary Completion Date
Oct 22, 2012Actual
Completion Date
Oct 10, 2013Actual
First Submitted Date
Mar 11, 2011
First Submission Date that Met QC Criteria
Mar 14, 2011
First Posted Date
Mar 15, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 11, 2016
Results First Submitted that Met QC Criteria
May 11, 2016
Results First Posted Date
Jun 17, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 16, 2019
Last Update Posted Date
Feb 4, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Urinary Bladder, Overactive
Keywords
Overactive bladder
MK-4618
tolterodine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,395Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: placebo
Placebo Comparator
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Part 1: vibegron 3 mg
Experimental
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.
Drug: Vibegron
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Part 1: vibegron 15 mg
Experimental
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.
Drug: Vibegron
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Part 1: vibegron 50 mg
Experimental
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.
Drug: Vibegron
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Part 1: vibegron 100 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vibegron
Drug
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.
Extension Study: vibegron 100 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline and Week 8
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.
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.
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.
Part 1: up to 8 weeks; Part 2: up to 4 weeks
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: up to 54 weeks (including 2-week follow-up)
Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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
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.
This was a 2-Part, randomized, double blind placebo- and active-controlled, parallel-group study of vibegron in men and women with Overactive Bladder (OAB). Participants who enrolled in Part 1 were not eligible to participate in Part 2. Participants who completed Part 1 or Part 2 were eligible to enroll in an optional 1-year safety extension.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
FG001
Part 1: Vibegron 3 mg
Periods
Title
Milestones
Reasons Not Completed
Treatment Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Austria
Canada
Denmark
Germany
Italy
Japan
Mexico
New Zealand
Norway
Peru
Poland
Puerto Rico
South Africa
South Korea
Sweden
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
Drug: Vibegron
Drug: Placebo matching tolterodine ER
Part 1: tolterodine ER 4 mg
Active Comparator
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
Drug: Tolterodine ER
Drug: Placebo matching vibegron
Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
Experimental
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.
Drug: Vibegron
Drug: Tolterodine ER
Drug: Placebo matching tolterodine ER
Part 2: placebo
Placebo Comparator
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Part 2: vibegron 100 mg
Experimental
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
Drug: Vibegron
Drug: Placebo matching tolterodine ER
Part 2: tolterodine ER 4 mg
Active Comparator
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
Drug: Tolterodine ER
Drug: Placebo matching vibegron
Part 2: vibegron 100 mg + tolterodine ER 4 mg
Experimental
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Drug: Vibegron
Drug: Tolterodine ER
Extension Study: vibegron 50 mg
Experimental
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.
Drug: Vibegron
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER
Extension Study: vibegron 100 mg
Experimental
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.
Drug: Vibegron
Drug: Placebo matching tolterodine ER
Extension Study: tolterodine ER 4 mg
Experimental
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.
Drug: Tolterodine ER
Drug: Placebo matching vibegron
Extension Study: vibegron 100 mg + tolterodine ER 4 mg
Experimental
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.
Drug: Vibegron
Drug: Tolterodine ER
Extension Study: vibegron 100 mg + tolterodine ER 4 mg
Extension Study: vibegron 50 mg
Part 1: vibegron 100 mg
Part 1: vibegron 15 mg
Part 1: vibegron 3 mg
Part 1: vibegron 50 mg
Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
Part 2: vibegron 100 mg
Part 2: vibegron 100 mg + tolterodine ER 4 mg
MK-4618
Tolterodine ER
Drug
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Extension Study: tolterodine ER 4 mg
Extension Study: vibegron 100 mg + tolterodine ER 4 mg
Part 1: tolterodine ER 4 mg
Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
Part 2: tolterodine ER 4 mg
Part 2: vibegron 100 mg + tolterodine ER 4 mg
Detrol®
Placebo matching vibegron
Drug
Participants received placebo matching vibegron tablets, taken orally each morning.
Extension Study: tolterodine ER 4 mg
Extension Study: vibegron 50 mg
Part 1: placebo
Part 1: tolterodine ER 4 mg
Part 1: vibegron 15 mg
Part 1: vibegron 3 mg
Part 1: vibegron 50 mg
Part 2: placebo
Part 2: tolterodine ER 4 mg
Placebo matching tolterodine ER
Drug
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Extension Study: vibegron 100 mg
Extension Study: vibegron 50 mg
Part 1: placebo
Part 1: vibegron 100 mg
Part 1: vibegron 15 mg
Part 1: vibegron 3 mg
Part 1: vibegron 50 mg
Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
Part 2: placebo
Part 2: vibegron 100 mg
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: up to 52 weeks
Baseline and Week 8
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.
Baseline and Week 8
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.
Baseline and Week 8
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.
Baseline and Week 52 of Extension 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.
Baseline and Week 52 of Extension 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.
Baseline and Week 52 of Extension 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.
Baseline and Week 52 of Extension Study
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.
FG002
Part 1: Vibegron 15 mg
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.
FG003
Part 1: Vibegron 50 mg
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.
FG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
FG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
FG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
FG007
Part 2: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
FG008
Part 2: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
FG009
Part 2: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
FG010
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
FG011
Extension Study: Vibegron 50 mg
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.
FG012
Extension Study: Vibegron 100 mg
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.
FG013
Extension Study: Tolterodine ER 4 mg
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.
FG014
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
FG000141 subjects
FG001144 subjects
FG002134 subjects
FG003150 subjects
FG004149 subjects
FG005135 subjects
FG006134 subjects
FG00764 subjects
FG008112 subjects
FG009122 subjects
FG010110 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG000131 subjects
FG001138 subjects
FG002128 subjects
FG003143 subjects
FG004142 subjects
FG005128 subjects
FG006126 subjects
FG00757 subjects
FG008106 subjects
FG009118 subjects
FG010107 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG00010 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG0047 subjects
FG0057 subjects
FG0068 subjects
FG0077 subjects
FG0086 subjects
FG0094 subjects
FG0103 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse event, non-fatal
FG0004 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG011223 subjects
FG012248 subjects
FG013240 subjects
FG014134 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
BG001
Part 1: Vibegron 3 mg
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.
BG002
Part 1: Vibegron 15 mg
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.
BG003
Part 1: Vibegron 50 mg
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.
BG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
BG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
BG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
BG007
Part 2: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
BG008
Part 2: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
BG009
Part 2: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
BG010
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000141
BG001144
BG002134
BG003150
BG004149
BG005135
BG006134
BG00764
BG008112
BG009122
BG010110
BG0111395
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00058.6± 9.0
BG00159.4± 8.7
BG00258.6± 8.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000128
BG001131
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.
Posted
Least Squares Mean
95% Confidence Interval
Micturitions
Baseline and Week 8
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
OG002
Part 1: Vibegron 15 mg
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.
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
Units
Counts
Participants
OG000141
OG001144
OG002132
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.16(-1.5 to -0.82)
OG001-1.62(-1.95 to -1.29)
OG002-1.61(-1.96 to -1.27)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.
0.056
Difference in least squares (LS) means
-0.46
2-Sided
95
-0.92
0.01
Superiority or Other
OG000
OG002
Primary
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.
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.
Posted
Number
Participants
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.
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
OG002
Part 1: Vibegron 15 mg
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.
Primary
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.
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.
Posted
Number
Participants
Part 1: up to 8 weeks; Part 2: up to 4 weeks
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
OG002
Part 1: Vibegron 15 mg
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.
Primary
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.
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.
Posted
Number
Participants
Extension: up to 54 weeks (including 2-week follow-up)
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
OG001
Extension Study: Vibegron 100 mg
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.
Primary
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.
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.
Posted
Number
Participants
Extension: up to 52 weeks
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
OG001
Extension Study: Vibegron 100 mg
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.
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.
Posted
Least Squares Mean
95% Confidence Interval
Urge incontinence episodes
Baseline and Week 8
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.
Posted
Least Squares Mean
95% Confidence Interval
Incontinence episodes
Baseline and Week 8
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.
Posted
Least Squares Mean
95% Confidence Interval
Strong urge episodes
Baseline and Week 8
ID
Title
Description
OG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
OG001
Part 1: Vibegron 3 mg
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.
OG002
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.
Posted
Least Squares Mean
95% Confidence Interval
Micturitions
Baseline and Week 52 of Extension Study
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
OG001
Extension Study: Vibegron 100 mg
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.
Posted
Least Squares Mean
95% Confidence Interval
Urge incontinence episodes
Baseline and Week 52 of Extension Study
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
Secondary
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.
Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.
Posted
Least Squares Mean
95% Confidence Interval
Incontinence episodes
Baseline and Week 52 of Extension Study
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
Secondary
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 analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.
Posted
Least Squares Mean
95% Confidence Interval
Strong urge episodes
Baseline and Week 52 of Extension Study
ID
Title
Description
OG000
Extension Study: Vibegron 50 mg
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.
OG001
Extension Study: Vibegron 100 mg
Time Frame
Part 1: up to approximately 10 weeks (including 2 week follow-up unless entering extension); Part 2: up to approximately 6 weeks (including 2 week follow-up unless entering extension); Extension: up to approximately 54 weeks (including 2 week follow-up)
Description
All participants as treated population consists of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Two participants who were randomized but not treated were excluded from the Part 1: vibegron 50 mg arm.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
2
141
32
141
EG001
Part 1: Vibegron 3 mg
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.
1
144
21
144
EG002
Part 1: Vibegron 15 mg
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.
0
134
27
134
EG003
Part 1: Vibegron 50 mg
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.
1
148
30
148
EG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
0
149
33
149
EG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
1
135
33
135
EG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
1
134
27
134
EG007
Part 2: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
0
64
6
64
EG008
Part 2: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
0
112
5
112
EG009
Part 2: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
2
122
21
122
EG010
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
0
110
20
110
EG011
Extension Study: Vibegron 50 mg
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.
14
223
59
223
EG012
Extension Study: Vibegron 100 mg
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.
8
248
73
248
EG013
Extension Study: Tolterodine ER 4 mg
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.
18
240
70
240
EG014
Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg
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.
1
134
38
134
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG0030 events0 affected148 at risk
EG0040 events0 affected149 at risk
EG0050 events0 affected135 at risk
EG0060 events0 affected134 at risk
EG0070 events0 affected64 at risk
EG0080 events0 affected112 at risk
EG0090 events0 affected122 at risk
EG0100 events0 affected110 at risk
EG0111 events1 affected223 at risk
EG0120 events0 affected248 at risk
EG0130 events0 affected240 at risk
EG0140 events0 affected134 at risk
Autoimmune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Gatrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Devise dislocation
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Periarthirits
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Cerebrovascluar accident
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Loss of conciousness
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Lung adenocarcinoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0011 events1 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected141 at risk
EG0010 events0 affected144 at risk
EG0020 events0 affected134 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0006 events5 affected141 at risk
EG0014 events4 affected144 at risk
EG0022 events2 affected134 at risk
EG0031 events1 affected148 at risk
EG0045 events5 affected149 at risk
EG0058 events7 affected135 at risk
EG0066 events6 affected134 at risk
EG0070 events0 affected64 at risk
EG0080 events0 affected112 at risk
EG0092 events2 affected122 at risk
EG0101 events1 affected110 at risk
EG0119 events9 affected223 at risk
EG01210 events9 affected248 at risk
EG01310 events10 affected240 at risk
EG0144 events2 affected134 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected141 at risk
EG0015 events5 affected144 at risk
EG0026 events6 affected134 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00015 events14 affected141 at risk
EG0013 events3 affected144 at risk
EG0028 events7 affected134 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0005 events5 affected141 at risk
EG0015 events5 affected144 at risk
EG0025 events5 affected134 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected141 at risk
EG0013 events3 affected144 at risk
EG0026 events6 affected134 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0008 events7 affected141 at risk
EG0013 events3 affected144 at risk
EG0026 events6 affected134 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0004 events3 affected141 at risk
EG0015 events5 affected144 at risk
EG0026 events6 affected134 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected141 at risk
EG0013 events2 affected144 at risk
EG0021 events1 affected134 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D053201
Urinary Bladder, Overactive
Ancestor Terms
ID
Term
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.
0.064
Difference in LS means
-0.45
2-Sided
95
-0.93
0.03
Superiority or Other
OG000
OG003
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.
0.007
Difference in LS means
-0.64
2-Sided
95
-1.11
-0.18
Superiority or Other
OG000
OG004
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.
< 0.001
Difference in LS means
-0.91
2-Sided
95
-1.37
-0.44
Superiority or Other
OG000
OG005
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.
0.026
Difference in LS means
-0.54
2-Sided
95
-1.02
-0.07
Superiority or Other
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
OG007
Part 2: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
OG008
Part 2: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
OG009
Part 2: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
OG010
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Units
Counts
Participants
OG000141
OG001144
OG002134
OG003148
OG004149
OG005135
OG006134
OG00764
OG008112
OG009122
OG010110
Title
Denominators
Categories
Title
Measurements
OG00066
OG00155
OG00270
OG00362
OG00470
OG00568
OG00669
OG00722
OG00837
OG00948
OG01040
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
OG007
Part 2: Placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
OG008
Part 2: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
OG009
Part 2: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
OG010
Part 2: Vibegron 100 mg + Tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Units
Counts
Participants
OG000141
OG001144
OG002134
OG003148
OG004149
OG005135
OG006134
OG00764
OG008112
OG009122
OG010110
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0024
OG0032
OG0042
OG0054
OG0063
OG0072
OG0084
OG0090
OG0102
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
Units
Counts
Participants
OG000223
OG001248
OG002240
OG003134
Title
Denominators
Categories
Title
Measurements
OG000134
OG001157
OG002158
OG00382
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
Units
Counts
Participants
OG000223
OG001248
OG002240
OG003134
Title
Denominators
Categories
Title
Measurements
OG00011
OG00114
OG00224
OG0037
OG002
Part 1: Vibegron 15 mg
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.
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
Units
Counts
Participants
OG000118
OG001113
OG002111
OG003121
OG004122
OG005100
OG006111
Title
Denominators
Categories
Title
Measurements
OG000-1.24(-1.52 to -0.95)
OG001-1.52(-1.81 to -1.23)
OG002-1.81(-2.10 to -1.51)
OG003-1.95(-2.23 to -1.67)
OG004-1.95(-2.23 to -1.67)
OG005-1.69(-2.00 to -1.38)
OG006-1.71(-2.01 to -1.42)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.167
Difference in LS means
-0.28
2-Sided
95
-0.68
0.12
Superiority or Other
OG000
OG002
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.005
Difference in LS means
-0.57
2-Sided
95
-0.97
-0.17
Superiority or Other
OG000
OG003
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
< 0.001
Difference in LS means
-0.72
2-Sided
95
-1.11
-0.33
Superiority or Other
OG000
OG004
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
< 0.001
Difference in LS means
-0.71
2-Sided
95
-1.10
-0.32
Superiority or Other
OG000
OG005
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.030
Difference in LS means
-0.46
2-Sided
95
-0.87
-0.04
Superiority or Other
OG002
Part 1: Vibegron 15 mg
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.
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
Units
Counts
Participants
OG000118
OG001113
OG002111
OG003121
OG004122
OG005100
OG006111
Title
Denominators
Categories
Title
Measurements
OG000-1.52(-1.84 to -1.21)
OG001-1.71(-2.02 to -1.39)
OG002-2.01(-2.33 to -1.69)
OG003-2.13(-2.43 to -1.82)
OG004-2.11(-2.41 to -1.80)
OG005-1.86(-2.20 to -1.52)
OG006-2.00(-2.32 to -1.68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.401
Difference in LS Means
-0.18
2-Sided
95
-0.61
0.25
Superiority or Other
OG000
OG002
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.029
Difference in LS Means
-0.48
2-Sided
95
-0.91
-0.05
Superiority or Other
OG000
OG003
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.005
Difference in LS Means
-0.60
2-Sided
95
-1.02
-0.18
Superiority or Other
OG000
OG004
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.007
Difference in LS Means
-0.58
2-Sided
95
-1.01
-0.16
Superiority or Other
OG000
OG005
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.140
Difference in LS Means
-0.34
2-Sided
95
-0.78
0.11
Superiority or Other
Part 1: Vibegron 15 mg
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.
OG003
Part 1: Vibegron 50 mg
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.
OG004
Part 1: Vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
OG005
Part 1: Tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
OG006
Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg
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.
Units
Counts
Participants
OG000141
OG001144
OG002132
OG003148
OG004148
OG005134
OG006134
Title
Denominators
Categories
Title
Measurements
OG000-1.59(-2.07 to -1.11)
OG001-1.77(-2.24 to -1.30)
OG002-2.27(-2.76 to -1.78)
OG003-2.36(-2.82 to -1.89)
OG004-2.83(-3.30 to -2.37)
OG005-2.53(-3.03 to -2.04)
OG006-2.73(-3.22 to -2.24)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.598
Difference in LS means
-0.18
2-Sided
95
-0.84
0.49
Superiority or Other
OG000
OG002
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.052
Difference in LS means
-0.67
2-Sided
95
-1.35
0.01
Superiority or Other
OG000
OG003
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.024
Difference in LS means
-0.76
2-Sided
95
-1.43
-0.10
Superiority or Other
OG000
OG004
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
< 0.001
Difference in LS means
-1.24
2-Sided
95
-1.90
-0.58
Superiority or Other
OG000
OG005
Constrained Longitudinal Data Analysis
Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.
0.007
Difference in LS means
-0.94
2-Sided
95
-1.62
-0.26
Superiority or Other
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.
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
Units
Counts
Participants
OG000223
OG001246
OG002240
OG003134
Title
Denominators
Categories
Title
Measurements
OG000-2.53(-2.87 to -2.20)
OG001-2.77(-3.08 to -2.45)
OG002-2.15(-2.47 to -1.83)
OG003-3.25(-3.67 to -2.83)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
Difference in LS means
-0.49
2-Sided
95
-1.00
0.03
Superiority or Other
OG002
OG003
Difference in LS means
-1.10
2-Sided
95
-1.62
-0.58
Superiority or Other
OG001
Extension Study: Vibegron 100 mg
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.
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
Units
Counts
Participants
OG000179
OG001200
OG002189
OG003112
Title
Denominators
Categories
Title
Measurements
OG000-2.43(-2.72 to -2.14)
OG001-2.15(-2.43 to -1.87)
OG002-2.23(-2.51 to -1.94)
OG003-2.44(-2.79 to -2.09)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
Difference in LS means
-0.29
2-Sided
95
-0.71
0.13
Superiority or Other
OG002
OG003
Difference in LS means
-0.21
2-Sided
95
-0.64
0.21
Superiority or Other
OG001
Extension Study: Vibegron 100 mg
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.
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.
Units
Counts
Participants
OG000179
OG001200
OG002189
OG003112
Title
Denominators
Categories
Title
Measurements
OG000-2.70(-3.03 to -2.36)
OG001-2.42(-2.74 to -2.09)
OG002-2.50(-2.83 to -2.17)
OG003-2.48(-2.89 to -2.07)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
Difference in LS means
-0.07
2-Sided
95
-0.56
0.43
Superiority or Other
OG002
OG003
Difference in LS means
0.02
2-Sided
95
-0.48
0.51
Superiority or Other
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.
OG002
Extension Study: Tolterodine ER 4 mg
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.
OG003
Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg
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.