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Trial record 59 of 179 for:    DCLRE1C

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03583372
Recruitment Status : Active, not recruiting
First Posted : July 11, 2018
Last Update Posted : April 30, 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 participants with OAB for up to 52 weeks.

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 : 507 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, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : January 5, 2020
Estimated Study Completion Date : January 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vibegron + Placebo to match Tolterodine Drug: Vibegron
Single daily dose 75mg
Other Name: RVT-901, MK-4618, KRP114V

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. Safety; Incidence of treatment-emergent adverse events for up to 52 weeks in participants with symptoms of overactive bladder (OAB) who previously completed treatment in study RVT-901-3003 [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change from baseline (CFB) at Week 52 in average number of micturitions per 24 hours in all OAB participants [ Time Frame: 52 weeks ]
  2. CFB at Week 52 in average number of urge urinary incontinence (UUI) episodes per 24 hours in OAB Wet participants [ Time Frame: 52 weeks ]
  3. CFB at Week 52 in average number of urgency episodes over 24 hours in all OAB participants [ Time Frame: 52 weeks ]
  4. CFB at Week 52 in average number of total urinary incontinence episodes over 24 hours in OAB Wet participants [ Time Frame: 52 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 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 participant's ability to comply with study procedures, or make participation in the study not in the participant'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 participant 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.

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): NCT03583372


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Sponsors and Collaborators
Urovant Sciences GmbH

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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03583372     History of Changes
Other Study ID Numbers: RVT-901-3004
2017-003294-33 ( EudraCT Number )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 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