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



Status:Active, not recruiting
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:June 14, 2018
End Date:January 5, 2020

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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

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


Inclusion Criteria:

1. Has completed participation 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 patient's ability
to comply with study procedures, or make participation in the study not in the
patient'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 patient 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.
We found this trial at
107
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Pembroke Pines, Florida 33027
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
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Albuquerque, New Mexico
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4161 Montgomery Boulevard Northeast
Albuquerque, New Mexico 87109
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Billings, Montana 59102
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Binghamton, New York 13901
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Boston, Massachusetts 02135
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16259 Sylvester Road Southwest
Burien, Washington 98166
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65 Highview Boulevard
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Cutler Bay, Florida 33189
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Endwell, New York 13760
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300 Grand Avenue
Englewood, New Jersey 07631
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Evanston, Illinois 60201
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841 Hospital Road
Indiana, Pennsylvania 15701
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Jackson, Tennessee 38301
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3059 South Maryland Parkway
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1727 Kirby Parkway
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Newport News, Virginia 23606
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Norfolk, Nebraska 68701
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Peachtree Corners, Georgia 30071
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