An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Vibegron; Drug: placebos; Drug: Tolterodine Tartrate ER

• Registration Number: NCT03583372
• Lead Sponsor: Urovant Sciences GmbH

Brief Summary

This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Primary Completion: 2019-06-13
• Study Completion: 2019-07-25
• Disposition First Submitted: 2020-06-12
• Disposition First Submitted QC: 2020-06-12
• Disposition First Posted: 2020-06-16
• Results First Submitted: 2021-01-11
• Results First Submitted QC: 2021-01-11
• Status Verified: 2021-02
• Results First Posted: 2021-02-03
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

1. Has completed participation in study RVT-901-3003.
2. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.

Exclusion Criteria

1. Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
2. Has coronary or neurovascular interventions planned during the duration of the study.
3. Has uncontrolled hyperglycemia (defined as fasting blood glucose >150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
4. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) > 100 beats per minute.
5. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
6. Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003.
7. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
8. Use of any prohibited medications as detailed in Section 7.7.3.
9. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
10. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
11. Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-3003.
12. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
13. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibegron + Placebo to match Tolterodine	placebos	-
Tolterodine + Placebo to match vibegron	placebos	-
Tolterodine + Placebo to match vibegron	Tolterodine Tartrate ER	-
Vibegron + Placebo to match Tolterodine	Vibegron	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Type of Treatment-emergent Adverse Event	up to 56 weeks	Adverse events were collected in participants 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline (CFB) at Week 52 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants	Baseline; Week 52	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 participant 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 participant got up for the day each morning and time the participant 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.
CFB at Week 52 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants	Baseline; Week 52	The number of UUI episodes is defined as the number of times a participant 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 participant got up for the day each morning and time participant 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 participants with evaluable data were analyzed.
CFB at Week 52 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Over 24 Hours in All OAB Participants	Baseline; Week 52	The number of urgency episodes is defined as the number of times a participant 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 participant got up for the day each morning and time the participant 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.
CFB at Week 52 in the Average Number of Total Urinary Incontinence Episodes Over 24 Hours in OAB Wet Participants	Baseline; Week 52	The number of total incontinence episodes is defined as the number of times a participant 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 participant got up for the day each morning and time the participant 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 = hour.

Trial Locations

Locations (106)

Coastal Clinical Research Inc.; 🇺🇸 Mobile, Alabama, United States

Clinical Research Consortium; 🇺🇸 Tempe, Arizona, United States

Noble Clinical Research; 🇺🇸 Tucson, Arizona, United States

Hope Clinical Research; 🇺🇸 Canoga Park, California, United States

Core Healthcare Group; 🇺🇸 Cerritos, California, United States

American Clinical Trials; 🇺🇸 Hawaiian Gardens, California, United States

Grossmont Center for Clinical Research; 🇺🇸 La Mesa, California, United States

Prime-Care Clinical Research; 🇺🇸 Laguna Hills, California, United States

Long Beach Clinical Trials LLC; 🇺🇸 Long Beach, California, United States

Downtown L.A. Research Center Inc.; 🇺🇸 Los Angeles, California, United States

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