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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Doral, Florida 33122
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1159
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
67
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
529
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
579
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New London, CT
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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...
795
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Pembroke Pines, Florida 33027
978
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1137
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
532
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Albuquerque, New Mexico
1333
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4161 Montgomery Boulevard Northeast
Albuquerque, New Mexico 87109
1329
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Billings, Montana 59102
1347
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Binghamton, New York 13901
398
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Boston, Massachusetts 02135
643
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Brandon, Florida 33511
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Brownsburg, Indiana
178
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Bryan, Texas 77802
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16259 Sylvester Road Southwest
Burien, Washington 98166
2007
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Canoga Park, California 91303
1987
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Cerritos, California 90703
1967
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28209
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98
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Cleveland, Ohio 44122
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Columbus, Ohio 43213
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65 Highview Boulevard
Columbus, Ohio 43207
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Cutler Bay, Florida 33189
1006
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Dayton, Ohio 45439
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Denver, Colorado 80246
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DeSoto, Texas 75115
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East Providence, Rhode Island 02914
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Edgewater, Florida 32132
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Edison, New Jersey 08837
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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
282
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Fort Mill, South Carolina
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Garden City, New York 11530
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Greensboro, North Carolina 27408
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Gurnee, IL
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Hartsdale, New York 10530
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Hawaiian Gardens, California 90716
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Hialeah, Florida 33012
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Hialeah, Florida 33016
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Houston, Texas 77098
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Houston, Texas 77030
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Hurst, Texas 76054
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841 Hospital Road
Indiana, Pennsylvania 15701
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Jackson, Tennessee 38301
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Jenkintown, Pennsylvania 19046
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Johnson City, Tennessee 37601
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Jupiter, Florida 33458
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La Mesa, California 91942
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La Vista, Nebraska 68128
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Laguna Hills, California 92653
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3059 South Maryland Parkway
Las Vegas, Nevada 89109
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Lawrenceville, New Jersey 08648
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Lexington, Kentucky 40509
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Lincoln, Nebraska 68510
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Long Beach, California 90806
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Los Angeles, California 90017
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1727 Kirby Parkway
Memphis, Tennessee 38120
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Meridian, Idaho 83642
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Miami, Florida 33144
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6850 Coral Way
Miami, Florida 33155
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8780 Southwest 8th Street
Miami, Florida 33174
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Middleburg Heights, Ohio 44130
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Mobile, Alabama 36608
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Murrieta, California 92563
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Myrtle Beach, South Carolina 29588
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New Orleans, Louisiana 70124
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New Port Richey, Florida 34652
810
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7114 Congress Street
New Port Richey, Florida 34655
808
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Newport News, Virginia 23606
405
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Norfolk, Nebraska 68701
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North Dartmouth, Massachusetts 02747
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Peachtree Corners, Georgia 30071
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Philadelphia, Pennsylvania 19114
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1050 Bower Hill Road
Pittsburgh, Pennsylvania 15243
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Pittsburgh, Pennsylvania 15243
162
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Pompano Beach, Florida 33060
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967 Oakwood Drive
Rochester, Michigan 48307
187
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2043
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Salt Lake City, Utah 84107
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San Diego, California 92123
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9040 Friars Road
San Diego, California 92108
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Shreveport, Louisiana 71106
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Simpsonville, South Carolina 29681
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Summerville, South Carolina 29485
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tempe, Arizona 85283
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Valley Village, California 91607
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Wadsworth, OH
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Watertown, Massachusetts 02472
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