A study to assess the long-term efficacy and safety of two medicines, solifenacin succinate and mirabegron, taken together or separately, in patients with overactive bladder

Phase 1

• Conditions: Overactive Bladder; MedDRA version: 18.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-28
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1800

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 with autonomic component or
bladder involvement, or systemic or central neurological disease such as
multiple sclerosis and Parkinson's disease with autonomic component or
bladder involvement). An autonomic component can be inferred when
autonomic functions are affected, including heart rate, blood pressure,
perspiration and digestion.
• 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 an average QTcF interval > 450 ms for males or > 470 ms
for females based on the triplicate ECGs completed at Screening 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