A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder

Phase 1

• Conditions: Overactive Bladder; MedDRA version: 14.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2012-005736-29-IT
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-28
• Study Completion: 2016-09-08
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1829

Inclusion Criteria

• Subject is male or female and at least 18 years of age;
• Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
• Subject has symptoms of wet” OAB for at least three months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1728
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 672

Exclusion Criteria

• Subject has neurological cause for detrusor overactivity (e.g.
neurogenic bladder, diabetic neuropathy or systemic or central
neurological disease such as multiple sclerosis and Parkinson's disease).
• Subject has chronic inflammation such as bladder pain syndrome /
interstitial cystitis, symptomatic bladder stones or any previous or
current radiation cystitis.
• Subject has moderate to severe hepatic impairment
• Subject has severe renal impairment
• Subject has a clinically significant abnormal ECG
• Subject has a concurrent malignancy or history of cancer (except
noninvasive skin cancer) within the last 5 years prior to screening.
• Subject has a QTcF interval > 450 ms for males or > 470 ms for
females or is at risk of QT prolongation (e.g., family history of long QT
syndrome, hypokalaemia).
• Subject has severe hypertension, which is defined as a sitting
average systolic blood pressure = 180 mmHg and/or average diastolic
blood pressure = 110 mmHg.
• In the opinion of the investigator the subject has clinically significant bladder outflow obstruction at risk of urinary retention;
• Subject has significant PVR volume (> 150 mL);
• Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator;
• Subject has an indwelling catheter or practices intermittent self-catheterization;
• Subject has evidence of urinary tract infection (UTI), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
• Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified