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

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT03583372

Run by

Urovant Sciences GmbH

People needed

506

Starts

2018-06-14

Expected to finish

2019-07-25

Last updated by the study team

2021-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Has coronary or neurovascular interventions planned during the duration of the study.
• 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.
• 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.
• Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
• 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.
• Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
• Use of any prohibited medications as detailed in Section 7.7.3.
• 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.
• 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.
• 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.
• Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
• Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.

Where it is running

• 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
• Tri Valley Urology Medical Group — Murrieta, California, United States
• Northern California Research — Sacramento, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• WR MCCCR — San Diego, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• Bayview Research Group LLC — Valley Village, California, United States
• Horizons Clinical Research Center — Denver, Colorado, United States
• Lynn Institute of Denver — Denver, Colorado, United States
• Clinical Research Consulting LLC — Milford, Connecticut, United States
• Coastal Connecticut Research LLC — New London, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• PAB Clinical Research — Brandon, Florida, United States
• Top Medical Research Inc. — Cutler Bay, Florida, United States
• Revival Research — Doral, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Coastal Clinical Research Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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