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Trial record 62 of 179 for:    DCLRE1C

A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB) (Empowur)

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ClinicalTrials.gov Identifier: NCT03492281
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Brief Summary:
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: vibegron Drug: Placebos Drug: Tolterodine Tartrate ER Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : February 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibegron + Placebo to match Tolterodine Drug: vibegron
single daily oral dose of vibegron 75mg for 12 weeks
Other Name: RVT-901, MK4618, KRP114V

Drug: Placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)

Placebo Comparator: Placebo to match vibegron + Placebo to match Tolterodine Drug: Placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)

Active Comparator: Tolterodine + Placebo to match vibegron Drug: Placebos
placebo to match vibegron (experimental drug) and tolterodine (active comparator)

Drug: Tolterodine Tartrate ER
active comparator
Other Name: Mariosea XL




Primary Outcome Measures :
  1. Efficacy; Change from baseline in average number of micturitions per 24 hours [ Time Frame: 12 weeks ]
    Change from baseline (CFB) in average number of micturitions per 24 hours (in all OAB patients)

  2. Efficacy; Channge from baseline in average number of urge urinary incontinence episodes per 24 hours [ Time Frame: 12 weeks ]
    Change from baseline in average number of urge urinary incontinence episodes per 24 hours (in OAB Wet patients)


Secondary Outcome Measures :
  1. CFB at Week 12 in average number of urgency episodes over 24 hours in all OAB patients [ Time Frame: 12 weeks ]
  2. Percent of OAB Wet patients with at least a 75% reduction from baseline in UUI episodes per 24 hours at Week 12 [ Time Frame: 12 weeks ]
  3. Percent of OAB Wet patients with a 100% reduction from baseline in UUI episodes per 24 hours at Week 12 [ Time Frame: 12 weeks ]
  4. Percent of all OAB patients with at least a 50% reduction from baseline in urgency episodes per 24 hours at Week 12 [ Time Frame: 12 weeks ]
  5. CFB at Week 12 in average number of total incontinence episodes over 24 hours in OAB Wet patients [ Time Frame: 12 weeks ]
  6. CFB at Week 12 in Coping Score from the Overactive Bladder Questionnaire Long Form (OAB-q LF) in all OAB patients [ Time Frame: 12 weeks ]
  7. CFB at Week 12 in average volume voided per micturition in all OAB patients [ Time Frame: 12 weeks ]
  8. CFB at Week 12 in Health-related Quality of Life (HRQL) Total Score from the OAB-q LF in all OAB patients [ Time Frame: 12 weeks ]
  9. CFB at Week 12 in Symptom Bother Score from the OAB-q-LF in all OAB patients [ Time Frame: 12 weeks ]
  10. Percent of all OAB patients with average number of micturitions < 8 per 24 hours at Week 12 [ Time Frame: 12 weeks ]
  11. Percent of OAB Wet patients with at least a 50% reduction from baseline in total incontinence episodes per 24 hours at Week 12 [ Time Frame: 12 weeks ]
  12. CFB at Week 12 in overall bladder symptoms based on Patient Global Impression of Severity (PGI-Severity) in all OAB patients [ Time Frame: 12 weeks ]
  13. CFB at Week 12 in overall control over bladder symptoms based on Patient Global Impression of Control (PGI-Control) in all OAB patients [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a history of OAB for at least 3 months prior to the Screening Visit.
  2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

  1. Patient had an average total daily urine volume > 3000 mL in the past 6 months or during the 14-day Run-in Period.
  2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
  3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
  4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
  5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.
  6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.
  7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
  8. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
  9. Has a requirement for an indwelling catheter or intermittent catheterization.
  10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
  11. 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) or, if in the opinion of the Investigator, is uncontrolled.
  12. Has evidence of diabetes insipidus.
  13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
  14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  15. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
  16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
  17. Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.
  18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
  19. Has hematuria, including microscopic hematuria according to pre-defined criteria.
  20. Has clinically significant electrocardiogram (ECG) abnormality.
  21. 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).
  22. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
  23. 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.
  24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492281


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Sponsors and Collaborators
Urovant Sciences GmbH

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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03492281     History of Changes
Other Study ID Numbers: RVT-901-3003
2017-003293-14 ( EudraCT Number )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Urovant Sciences GmbH:
Beta-3 adrenergic receptor (β3-AR) agonists
Incontinence
OAB
Vibegron
Urge urinary incontinence
Urinary bladder, overactive
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Agents

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents