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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01745094
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: mirabegron Drug: solifenacin Phase 4

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Marketing Clinical Study of Mirabegron -Add-on Therapy With Mirabegron in Patients With Overactive Bladder Under Treatment With Solifenacin-
Study Start Date : October 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Concomitant Group
concomitant administration of mirabegron to solifenacin treated patients
Drug: mirabegron
oral
Other Names:
  • YM178
  • Betanis
Drug: solifenacin
oral
Other Names:
  • Vesicare
  • YM905


Outcome Measures

Primary Outcome Measures :
  1. Safety assessed by the incidence of adverse events, vial signs lab tests, 12-lead ECGs, QTc-intervals Urine volume and uroflowmetry [ Time Frame: for 16 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in OABSS (OverActive Bladder Symptom Score) [ Time Frame: Baseline and Week 16 ]
  2. Change from baseline in OAB-q (OverActive Bladder questionnaire) short form (QAB-q SF) score [ Time Frame: Baseline and Week 16 ]
  3. Change from baseline in mean number of micturition episodes per 24 hour [ Time Frame: Baseline and Week 16 ]
  4. Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: Baseline and Week 16 ]
  5. Change from baseline in mean number of urinary incontinence episodes per 24 hours [ Time Frame: Baseline and Week 16 ]
  6. Change from baseline in mean volume voided per micturition [ Time Frame: Baseline and Week 16 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745094


Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01745094     History of Changes
Other Study ID Numbers: 178-CL-110
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Astellas Pharma Inc:
mirabegron
solifenacin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents