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 |
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.
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
sites
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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4161 Montgomery Boulevard Northeast
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
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1050 Bower Hill Road
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
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251 Leatherman Road
Wadsworth, Ohio 44281
Wadsworth, Ohio 44281
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