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    Summary
    EudraCT Number:2017-003294-33
    Sponsor's Protocol Code Number:RVT-901-3004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-003294-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Empowur (Empower OAB Patients with Vibegron for Better Urgency Control)
    A.4.1Sponsor's protocol code numberRVT-901-3004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUrovant Sciences GmbH
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUrovant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUrovant Sciences GmbH
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street AddressViaduktstrasse 8
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 225 4202
    B.5.6E-mailinfo@urovant.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namevibegron
    D.3.2Product code RVT-901
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIBEGRON
    D.3.9.1CAS number 1190389-15-1
    D.3.9.2Current sponsor codeRVT-901
    D.3.9.4EV Substance CodeSUB189006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Mariosea
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nametolterodine tartrate extended release
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOLTERODINE TARTRATE
    D.3.9.3Other descriptive nameTOLTERODINE TARTRATE
    D.3.9.4EV Substance CodeSUB61874
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult men and women with either:
    * OAB Wet
    * OAB Dry
    E.1.1.1Medical condition in easily understood language
    Overactive bladder (OAB)
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Safety Objective: To evaluate the safety and tolerability of vibegron for up to 52 weeks in patients with symptoms of overactive bladder (OAB) who previously completed treatment in study RVT-901-3003
    E.2.2Secondary objectives of the trial
    Secondary and Exploratory Efficacy Objectives:
    * To evaluate the efficacy of vibegron in patients with symptoms of OAB
    * To evaluate the effect of vibegron on patient-perceived outcomes in patients with symptoms of OAB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has completed participation in study RVT-901-3003.
    2. Willing and able to provide written informed consent.
    3. For females of reproductive potential: Agrees to remain abstinent or use (or have their male partner use) an acceptable method of birth control (as defined in Section 5.2.1) each time the patient has intercourse until the Follow-up Visit.
    4. For females of reproductive potential: Agrees not to donate ova (eggs) until at least 1 month after the last dose of Study Treatment.
    5. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.
    6. Has completed a minimum of 4 Complete Diary Days for study RVT-901-3003 Week 12.
    7. Is ambulatory and in good general physical and mental health as determined by the Investigator.
    8. In the opinion of the Investigator, is able and willing to comply with the requirements of the protocol, including completing electronic versions of questionnaires, the Voiding Diary, and Voided Volume Diary (will require ability to collect, measure, and record voided volume by herself/himself using a graduated urine collection and measurement container [provided by the Sponsor, if needed]).
    E.4Principal exclusion criteria
    1. Was unable to complete participation in study RVT-901-3003 for any reason.
    2. 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. Includes any serious or unstable, clinically relevant change in gastrointestinal, renal, hepatic, cardiovascular, lymphatic, or psychiatric, or other medical disorder during the RVT-901-3003 study
    3. Has coronary or neurovascular interventions planned during the duration of the study.
    4. 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.
    5. 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.
    a. Patients who have systolic blood pressures ≥ 160 mm Hg or < 180 mm Hg are excluded, unless deemed by the Investigator and/or Medical Monitor as safe to proceed in this study and able to complete the study per protocol; these patients must be on stable hypertension medication for at least 90 days.
    b. All patients with signs and symptoms of uncontrolled hypertension, regardless of blood pressure measurement, are excluded from the study. These include, but are not limited to neurological symptoms or findings, hematuria, proteinuria, retinopathy, unstable angina, acute heart failure.
    6. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the patient to risk by participating in the study
    7. 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.
    8. Has an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
    9. Use of any prohibited medications as detailed in Section 7.7.3.
    10. 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.
    11. 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.
    12. 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.
    13. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
    14. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint: Incidence of any adverse event by system organ class and preferred term
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    * Change from baseline (CFB) at Week 52 in average number of micturitions per 24 hours in all OAB patients
    * CFB at Week 52 in average number of urge urinary incontinence (UUI) episodes per 24 hours in OAB Wet patients
    * CFB at Week 52 in average number of urgency episodes (need to urinate immediately) over 24 hours in all OAB patients
    * Percent of all OAB patients with a 50% reduction from baseline in urgency episodes (need to urinate immediately) per 24 hours at Week 52
    * Percent of OAB Wet patients with a 75% reduction from baseline in UUI episodes per 24 hours at Week 52
    * CFB at Week 52 in average number of total urinary incontinence episodes over 24 hours in OAB Wet patients
    * CFB at Week 52 in average volume voided per micturition in all OAB patients
    * CFB at Week 52 in Coping Score from the OAB-q LF (1 week recall) in all OAB patients
    * CFB at Week 52 in Health-related Quality of Life (HRQL) Total Score from the OAB-q LF (1-week recall) in all OAB patients
    * CFB at Week 52 in Symptom Bother Score from the OAB-q-LF (1-week recall) in all OAB patients

    Exploratory Endpoints:
    * Percent of OAB Wet patients with zero UUI episodes at Week 52
    * Percent of all OAB patients with average number of micturitions < 8 per 24 hours at Week 52
    * Percent of OAB Wet patients with a 50% reduction from baseline in total incontinence episodes per 24 hours at Week 52
    * Percent of OAB Wet patients with zero UUI episodes at Week 52
    * CFB in percent of Diary Days with zero UUI episodes at Week 52 in OAB Wet patients
    * CFB at Week 52 in percent of dry diary days (zero UUI episodes) in OAB Wet patients
    * For all OAB patients with ≥ 1 night time voids associated with urgency (NVU) at baseline, CFB at Week 52 in the average number of NVU per 24 hours
    * CFB at Week 52 in overall bladder symptoms based on Patient Global Impression of Severity (PGI-Severity) in all OAB patients
    * CFB at Week 52 in overall control over bladder symptoms based on Patient Global Impression of Control (PGI-Control) in all OAB patients
    * CFB at Week 52 in overall symptom frequency based on Patient Global Impression of Symptom Frequency (PGI-Frequency) in all OAB patients
    * CFB at Week 52 in overall urgency-related leakage over bladder symptoms based on Patient Global Impression of Urgency-Related Leakage (PGI-Leakage) in all OAB Wet patients
    * Overall change of bladder symptoms based on Patient Global Impression of Change (PGI-Change) in all OAB patients at Week 52
    * CFB at Week 52 in Concern Score from the OAB-q-LF (1-week recall) in all OAB patients
    * CFB at Week 52 in Sleep Score from the OAB-q-LF (1-week recall) in all OAB patients
    * CFB at Week 52 in Social Interaction Score from the OAB-q-LF (1-week recall) in all OAB patients
    * CFB at Week 52 in scores of the Work Productivity and Activity Impairment Questionnaire-Urinary Symptoms (WPAI-US)
    * CFB at Week 52 in scores of the EQ-5D in all OAB patients
    * CFB at Week 52 in average number of nighttime voids for all patients
    * CFB at Week 52 in average number of nighttime voids for patients with nocturia at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Estonia
    Hungary
    Latvia
    Lithuania
    Poland
    Slovakia
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects would just revert to the normal standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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