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

This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01745094
First received: December 6, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

December 6, 2012
December 6, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
Safety assessed by the incidence of adverse events, vial signs labo-tests, 12-lead ECGs, QTc-intervals Urine volume and uroflowmetry [ Time Frame: for 16 Weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Change from baseline in OABSS (OverActive Bladder Symptom Score) [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in OAB-q (OverActive Bladder questionnaire) short form (QAB-q SF) score [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of micturition episodes per 24 hour [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urinary incontinence episodes per 24 hours [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean volume voided per micturition [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
Post-Marketing Clinical Study of Mirabegron -Add-on Therapy With Mirabegron in Patients With Overactive Bladder Under Treatment With Solifenacin-

The purpose of this study is to evaluate the safety and efficacy of concomitant use of mirabegron in patients with overactive bladder under treatment with solifenacin.

The duration of the study will be a total of 18 weeks including a 2-week screening period and 16 week treatment period. At week 8 visit, the dose of mirabegron can be increased based on agreement of the subject if mirabegron, in the opinion of the investigator or sub-investigator, is not fully effective.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Overactive Bladder
  • Drug: mirabegron
    oral
    Other Names:
    • YM178
    • Betanis
  • Drug: solifenacin
    oral
    Other Names:
    • YM905
    • Vesicare
Experimental: Concomitant Group
concomitant administration of mirabegron to solifenacin treated patients
Interventions:
  • Drug: mirabegron
  • Drug: solifenacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female: postmenopausal OAB outpatient
  • Male: OAB outpatient who has no wish to have children in the future
  • Patient has been under treatment with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
  • Patient has a total OABSS score of ≥3 points and a Question 3 score ≥2 points

Exclusion Criteria:

  • Patient has 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 has 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 has 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 has received surgical therapy that may affect the urinary tract function within 24 wk before the start of the screening period
Both
20 Years and older
No
Contact: Clinical Development Administration Dept. clintrialtrials_info@jp.astellas.com
Japan
 
NCT01745094
178-CL-110
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Inc
Astellas Pharma Inc
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP