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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01314872
First received: March 11, 2011
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: May 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Urinary Bladder, Overactive
Interventions: Drug: Vibegron
Drug: Tolterodine ER
Drug: Placebo matching vibegron
Drug: Placebo matching tolterodine ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.
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.
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.
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.
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.
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.
Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
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.
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.
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.
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.
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.
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.
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.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Part 1: Placebo     Part 1: Vibegron 3 mg     Part 1: Vibegron 15 mg     Part 1: Vibegron 50 mg     Part 1: Vibegron 100 mg     Part 1: Tolterodine ER 4 mg     Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg     Part 2: Placebo     Part 2: Vibegron 100 mg     Part 2: Tolterodine ER 4 mg     Part 2: Vibegron 100 mg + Tolterodine ER 4 mg     Extension Study: Vibegron 50 mg     Extension Study: Vibegron 100 mg     Extension Study: Tolterodine ER 4 mg     Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg  
STARTED     141     144     134     150     149     135     134     64     112     122     110     0     0     0     0  
COMPLETED     131     138     128     143     142     128     126     57     106     118     107     0     0     0     0  
NOT COMPLETED     10     6     6     7     7     7     8     7     6     4     3     0     0     0     0  
Protocol Violation                 2                 1                 1                 0                 1                 0                 0                 0                 0                 1                 1                 0                 0                 0                 0  
Physician Decision                 0                 1                 0                 1                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0                 0                 1                 0                 2                 0                 0                 0                 0                 0                 0                 0  
Adverse event, non-fatal                 4                 2                 3                 2                 2                 4                 4                 2                 3                 0                 1                 0                 0                 0                 0  
Withdrawal by Subject                 3                 1                 0                 2                 3                 1                 3                 2                 2                 2                 1                 0                 0                 0                 0  
Lost to Follow-up                 0                 1                 2                 2                 1                 1                 1                 1                 1                 0                 0                 0                 0                 0                 0  

Period 2:   Period 2
    Part 1: Placebo     Part 1: Vibegron 3 mg     Part 1: Vibegron 15 mg     Part 1: Vibegron 50 mg     Part 1: Vibegron 100 mg     Part 1: Tolterodine ER 4 mg     Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg     Part 2: Placebo     Part 2: Vibegron 100 mg     Part 2: Tolterodine ER 4 mg     Part 2: Vibegron 100 mg + Tolterodine ER 4 mg     Extension Study: Vibegron 50 mg     Extension Study: Vibegron 100 mg     Extension Study: Tolterodine ER 4 mg     Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg  
STARTED     0     0     0     0     0     0     0     0     0     0     0     223     248     240     134  
COMPLETED     0     0     0     0     0     0     0     0     0     0     0     175     188     187     110  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0     48     60     53     24  
Protocol Violation                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 3                 3                 2                 0  
Non-compliance with study drug                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 3                 3                 1                 2  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 7                 12                 9                 2  
Pregnancy                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Study terminated by Sponsor                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 2                 2                 3                 0  
Adverse event, non-fatal                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 13                 16                 24                 9  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 14                 17                 12                 4  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 6                 7                 2                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.
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.
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.
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.
Part 2: Placebo Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    Part 1: Placebo     Part 1: Vibegron 3 mg     Part 1: Vibegron 15 mg     Part 1: Vibegron 50 mg     Part 1: Vibegron 100 mg     Part 1: Tolterodine ER 4 mg     Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg     Part 2: Placebo     Part 2: Vibegron 100 mg     Part 2: Tolterodine ER 4 mg     Part 2: Vibegron 100 mg + Tolterodine ER 4 mg     Total  
Number of Participants  
[units: participants]
  141     144     134     150     149     135     134     64     112     122     110     1395  
Age  
[units: Years]
Mean (Standard Deviation)
  58.6  (9.0)     59.4  (8.7)     58.6  (8.1)     60.3  (8.7)     60.3  (8.3)     59.1  (8.1)     59.4  (8.5)     56.3  (10.6)     57.2  (10.1)     57.9  (10.9)     55.5  (11.7)     58.6  (9.3)  
Gender  
[units: Participants]
                       
Female     128     131     125     129     135     121     119     57     101     110     95     1251  
Male     13     13     9     21     14     14     15     7     11     12     15     144  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Primary:   Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study. ]

3.  Primary:   Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE   [ Time Frame: Part 1: up to 8 weeks; Part 2: up to 4 weeks ]

4.  Primary:   Extension Study: Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Extension: up to 54 weeks (including 2-week follow-up) ]

5.  Primary:   Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE   [ Time Frame: Extension: up to 52 weeks ]

6.  Secondary:   Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8   [ Time Frame: Baseline and Week 8 ]

7.  Secondary:   Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8   [ Time Frame: Baseline and Week 8 ]

8.  Secondary:   Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8   [ Time Frame: Baseline and Week 8 ]

9.  Secondary:   Extension Study: Change From Baseline in Average Daily Micturitions at Week 52   [ Time Frame: Baseline and Week 52 of Extension Study ]

10.  Secondary:   Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52   [ Time Frame: Baseline and Week 52 of Extension Study ]

11.  Secondary:   Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52   [ Time Frame: Baseline and Week 52 of Extension Study ]

12.  Secondary:   Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52   [ Time Frame: Baseline and Week 52 of Extension Study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01314872     History of Changes
Other Study ID Numbers: 4618-008
132241 ( Registry Identifier: JAPIC-CTI )
2010-022121-15 ( EudraCT Number )
2011-002533-18 ( EudraCT Number )
Study First Received: March 11, 2011
Results First Received: May 11, 2016
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration