Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease
Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)
1 other identifier
observational
316
1 country
28
Brief Summary
This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedOctober 7, 2015
October 1, 2015
2.2 years
October 6, 2015
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in electrocardiogram parameters pre- and post- administration of mirabegron
Baseline and up to four weeks
Incidence rate of cardiovascular system adverse reactions
Up to four weeks
Safety assessed by biochemistry laboratory tests
Up to four weeks
Safety assessed by incidence of adverse events
Up to four weeks
Secondary Outcomes (1)
Changes in overactive bladder (OAB) symptoms
Baseline and up to four weeks
Study Arms (1)
Mirabegron group
Subjects with overactive bladder and cardiovascular disease prescribed mirabegron
Interventions
Eligibility Criteria
Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron
You may qualify if:
- having coexisting cardiovascular disease or a history of cardiovascular diseases
- having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration)
You may not qualify if:
- having serious cardiovascular disease
- having significant long QT (QTc \> 500 msec)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Site JP81013
Aichi, Japan
Site JP81014
Aichi, Japan
Site JP81005
Chiba, Japan
Site JP81006
Chiba, Japan
Site JP81007
Chiba, Japan
Site JP81026
Fukuoka, Japan
Site JP81027
Fukuoka, Japan
Site JP81001
Hokkaido, Japan
Site JP81002
Hokkaido, Japan
Site JP81021
Hyōgo, Japan
Site JP81022
Hyōgo, Japan
Site JP81023
Hyōgo, Japan
Site JP81024
Hyōgo, Japan
Site JP81025
Hyōgo, Japan
Site JP81028
Kagoshima, Japan
Site JP81011
Kanagawa, Japan
Site JP81012
Kanagawa, Japan
Site JP81003
Niigata, Japan
Site JP81016
Osaka, Japan
Site JP81017
Osaka, Japan
Site JP81018
Osaka, Japan
Site JP81019
Osaka, Japan
Site JP81020
Osaka, Japan
Site JP81004
Saitama, Japan
Site JP81015
Shizuoka, Japan
Site JP81008
Tokyo, Japan
Site JP81009
Tokyo, Japan
Site JP81010
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2015
First Posted
October 7, 2015
Study Start
December 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
October 7, 2015
Record last verified: 2015-10