A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

NCT01745094 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 178-CL-110
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.

Conditions

Overactive Bladder

Keywords

mirabegron; solifenacin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.

  From first dose of study drug up to weeks 16

Secondary Outcomes (14)

• Change From Baseline in OABSS Total Score

  Baseline and week 8, 16

• Number of Participants Who Achieved Normalization for OABSS Total Score

  Week 8 and 16

• Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score

  Baseline and week 8, 16

• Change From Baseline in OAB-q SF Total HRQL Score

  Baseline and week 8, 16

• Change From Baseline in the Number of Micturitions Per 24 Hours

  Baseline and week 4, 8, 12, 16

Study Arms (1)

Concomitant Group

EXPERIMENTAL

concomitant administration of mirabegron to solifenacin treated patients

Drug: mirabegron; Drug: solifenacin

Interventions

mirabegron DRUG

oral

Also known as: YM178, Betanis

Concomitant Group

solifenacin DRUG

oral

Also known as: Vesicare, YM905

Concomitant Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female: postmenopausal OAB outpatient
• Male: OAB outpatient who did not wish to have children at all
• Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
• Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points

You may not qualify if:

• Patient had a residual urine volume of ≥100 mL or a maximum flow rate \<5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
• Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
• Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Astellas Pharma Inc.

motoko.ida@astellas.com

+81-3-3244-0512 Ext:

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 7, 2012
• Study Start: October 1, 2012
• Primary Completion: July 23, 2013
• Study Completion: July 23, 2013
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2017-12

Locations

JP (5)