Clinical Trial Results:
An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Summary
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EudraCT number |
2017-003294-33 |
Trial protocol |
LV HU LT |
Global end of trial date |
25 Jul 2019
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Apr 2021
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First version publication date |
27 Jan 2021
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RVT-901-3004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03583372 | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Urovant Sciences GmbH
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Sponsor organisation address |
Viaduktstrasse 8 4051, Basel, Switzerland,
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Public contact |
Clinical Trial Information Contact, Urovant Sciences GmbH, 41 (42) 2155999, info@urovant.com
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Scientific contact |
Clinical Trial Information Contact, Urovant Sciences GmbH, 41 (42) 2155999, info@urovant.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Jun 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jul 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study was designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in subjects with overactive bladder (OAB) for up to 52 weeks.
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Protection of trial subjects |
Each investigator obtained approval of the study from a properly constituted Institutional Review Board (IRB), Research Ethics Board (REB), or Independent Ethics Committee (IEC) prior to study initiation. This study was conducted in compliance with Good Clinical Practice (GCP). Prior to participating in any study procedures, the study was discussed with each subject and/or with the subject’s legally authorized representative, and written informed consent was obtained.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jun 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 506
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Worldwide total number of subjects |
506
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
271
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From 65 to 84 years |
231
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85 years and over |
4
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Of the 506 subjects with overactive bladder (OAB) who completed 12 weeks in Study RVT-901-3003 (NCT03492281) and were screened and randomized for this extension study, 505 received at least 1 dose of double-blind study drug (Safety Set Extension [SAF-Ext]: vibegron, N = 273; tolterodine, N = 232). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Assessor, Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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40 Weeks Vibegron 75 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Vibegron
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Vibegron 75-mg tablet, administered as a single tablet, orally, once daily
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Arm title
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52 Weeks Vibegron 75 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Vibegron
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Vibegron 75-mg tablet, administered as a single tablet, orally, once daily
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Arm title
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40 Weeks Tolterodine ER 4 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tolterodine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Tolterodine ER 4-mg capsule, administered as a single capsule, orally, once daily
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Arm title
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52 Weeks Tolterodine ER 4 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tolterodine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Tolterodine ER 4-mg capsule, administered as a single capsule, orally, once daily
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Of the 506 subjects with overactive bladder (OAB) who completed 12 weeks in Study RVT- 901-3003 and were screened and randomized for this extension study, 505 received at least 1 dose of double-blind study drug (Safety Set Extension [SAF-Ext]). Baseline data are reported for members of the SAF-Ext. |
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Baseline characteristics reporting groups
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Reporting group title |
40 Weeks Vibegron 75 mg
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Reporting group description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
52 Weeks Vibegron 75 mg
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Reporting group description |
Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
40 Weeks Tolterodine ER 4 mg
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Reporting group description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
52 Weeks Tolterodine ER 4 mg
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Reporting group description |
Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
40 Weeks Vibegron 75 mg
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Reporting group description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||
Reporting group title |
52 Weeks Vibegron 75 mg
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Reporting group description |
Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||
Reporting group title |
40 Weeks Tolterodine ER 4 mg
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Reporting group description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||
Reporting group title |
52 Weeks Tolterodine ER 4 mg
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Reporting group description |
Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||
Subject analysis set title |
Overall vibegron 75 mg: SAF-Ext Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Subjecs who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. The SAF-Ext is comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004.
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Subject analysis set title |
Overall tolterodine ER 4 mg: SAF-Ext Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Subjects who received 40 weeks and 52 weeks tolterodine ER 4 mg. Subjects who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Subjects who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. The SAF-Ext is comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004.
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Subject analysis set title |
40 Weeks Vibegron 75 mg: FAS-Ext Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Full Analysis Set Extension (FAS-Ext) Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable change from Baseline (CFB) micturition measurement in this extension study.
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Subject analysis set title |
52 Weeks Vibegron 75 mg: FAS-Ext Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.
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Subject analysis set title |
40 Weeks Tolterodine ER 4 mg: FAS-Ext Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.
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Subject analysis set title |
52 Weeks Tolterodine ER 4 mg: FAS-Ext Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. FAS-Ext Population: all randomized OAB subjects who took at least 1 dose of double-blind study treatment during this extension study and had at least 1 subsequent evaluable CFB micturition measurement in this extension study.
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Subject analysis set title |
40 Weeks Vibegron 75 mg: FAS-Ext-I Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks. Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.
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Subject analysis set title |
52 Weeks Vibegron 75 mg: FAS-Ext-I Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized in Study RVT-901-3003 to receive vibegron 75 milligrams (mg) were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to vibegron 75 mg were to receive 52 weeks total of vibegron. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.
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Subject analysis set title |
40 Weeks Tolterodine ER 4 mg: FAS-Ext-I Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of tolterodine extended release (ER) 4 mg once daily for 40 weeks. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.
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Subject analysis set title |
52 Weeks Tolterodine ER 4 mg: FAS-Ext-I Population
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects who had been randomized in Study RVT-901-3003 to receive tolterodine ER 4 mg were to continue their same treatment once daily in a blinded fashion for 40 weeks. Thus, through participation in both Study RVT-901-3003 and this extension study, subjects originally randomized to tolterodine ER 4 mg were to receive 52 weeks total of tolterodine ER. FAS-Ext-I Population: all randomized OAB Wet subjects who were included in the FAS-I population in Study RVT-901-3003, who took at least 1 dose of double-blind study treatment in this extension study and had at least 1 subsequent evaluable CFB UUI measurement.
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End point title |
Number of Subjects with the Indicated Type of Treatment-emergent Adverse Event [1] | |||||||||||||||||||||||||||||||||||||||
End point description |
Adverse events were collected in subjects with overactive bladder (OAB) who previously completed treatment in Study RVT-901-3003. The treatment-emergent period was defined as the period of time from the first dose date of the active double-blind study treatment, whether in Study RVT-901-3003 or Study RVT-901-3004, through 28 days after the last dose of study treatment, or the date of initiation of another investigational agent or surgical intervention, whichever occurred first.
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End point type |
Primary
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End point timeframe |
up to 56 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis was not conducted. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline (CFB) at Week 52 in the Average Number of Micturitions per 24 Hours in all Overactive Bladder (OAB) Subjects [2] | ||||||||||||
End point description |
A micturition/void is defined as “Urinated in Toilet” as indicated on the Patient Voiding Diary (PVD). The number of micturitions is defined as the number of times a subject voided in the toilet as indicated in the PVD. The average daily number of micturitions was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of micturitions that occurred on a Complete Diary Day (CDD) divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the mixed model for repeated measures (MMRM) were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
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End point type |
Secondary
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End point timeframe |
Baseline; Week 52
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Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis. |
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Notes [3] - Full Analysis Set Extension (FAS-Ext) Population. Only subjects with evaluable data were analyzed. [4] - FAS-Ext Population. Only subjects with evaluable data were analyzed. |
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No statistical analyses for this end point |
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End point title |
CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes per 24 Hours in OAB Wet Subjects [5] | ||||||||||||
End point description |
The number of UUI episodes is defined as the number of times a subject had checked “urge” as the main reason for the leakage in the PVD, regardless of whether more than one reason for leakage in addition to “urge” was checked. The average daily number of UUI episodes was calculated using the daily entries in the PVD (which was to be completed prior to each study visit) as the total number of UUI episodes that occurred on a CDD divided by the number of CDDs in the PVD. CFB was calculated as the post-BL value minus the BL value. "Per 24 hours” corresponds to one Diary Day (i.e., time between when subject got up for the day each morning and time subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. Only subjects with evaluable data were analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline; Week 52
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Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis. |
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Notes [6] - Full Analysis Set Extension for Incontinence (FAS-Ext-I) Population [7] - FAS-Ext-I Population |
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No statistical analyses for this end point |
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End point title |
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) over 24 Hours in All OAB Subjects [8] | ||||||||||||
End point description |
The number of urgency episodes is defined as the number of times a subject had checked “need to urinate immediately” on a CDD divided by the number of CDDs in the PVD. CFB is calculated as the post-BL value minus the BL value. "Over 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: OAB type (Wet versus Dry) and sex.
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End point type |
Secondary
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End point timeframe |
Baseline; Week 52
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Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis. |
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Notes [9] - FAS-Ext Population. Only subjects with evaluable data were analyzed. [10] - FAS-Ext Population. Only subjects with evaluable data were analyzed. |
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No statistical analyses for this end point |
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End point title |
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes over 24 Hours in OAB Wet Subjects [11] | ||||||||||||
End point description |
The number of total incontinence episodes is defined as the number of times a subject had checked the accidental urine leakage box in the PVD, including for reasons of “urge,” “stress,” or “other.” CFB was calculated as the post-BL value minus the BL value. "Over 24 hours” corresponds to one Diary Day (i.e., time between when the subject got up for the day each morning and time the subject got up for the day the next morning as recorded in the PVD). Covariates included in the MMRM were study visit, treatment, treatment by study visit interaction, Baseline, and the statistically significant terms in Study RVT-901-3003: sex. hr = hours.
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End point type |
Secondary
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End point timeframe |
Baseline; Week 52
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Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Per protocol, only the 52-week treatment groups were included in the statistical analysis. |
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Notes [12] - FAS-Ext-I Population. Only subjects with evaluable data were analyzed. [13] - FAS-Ext-I Population. Only subjects with evaluable data were analyzed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
up to 56 weeks
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Adverse event reporting additional description |
Treatment-emergent adverse events were collected in members of the Safety Set Extension, comprised of all subjects who received at least one dose of double-blind study treatment during RVT-901-3004. Subjects were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Overall vibegron 75 mg
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Reporting group description |
Subjects who received 40 weeks and 52 weeks vibegron 75 milligrams (mg). Subjects who had been randomized to the placebo group in Study RVT-901-3003 were randomized to receive blinded study treatment of vibegron 75 mg once daily for 40 weeks in RVT-901-3004. Subjects who received 52 weeks vibegron 75 mg were randomized to receive vibegron 75 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall tolterodine ER 4 mg
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Reporting group description |
Subjects who received 40 weeks and 52 weeks tolterodine ER 4 mg. Subjects who had been randomized to the placebo group in RVT-901-3003 were randomized to receive blinded study treatment of tolterodine ER 4 mg once daily for 40 weeks in Study RVT-901-3004. Subjects who received 52 weeks tolterodine ER 4 mg were randomized to receive tolterodine ER 4 mg in both studies. Subjects were stratified by Baseline Overactive Bladder Type (Wet versus Dry) and sex. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |