Overactive BladderNCT02570035
Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease
An observational study of Overactive Bladder and Cardiovascular Disease, run by Astellas Pharma Inc at 28 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overactive Bladder, Cardiovascular Disease
- What is being tested?
- Mirabegron
- Type of treatment
- Pill or oral medicine
- How many people
- 316 participants
- Where
- 28 sitesJapan
- Study dates
- Dec 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron
Who may be able to join
- 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)
Who cannot join
- having serious cardiovascular disease
- having significant long QT (QTc > 500 msec)
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Japan28 sites
Site JP81013
Aichi
Site JP81014
Aichi
Site JP81005
Chiba
Site JP81006
Chiba
Site JP81007
Chiba
Site JP81026
Fukuoka
Site JP81027
Fukuoka
Site JP81001
Hokkaido
Site JP81002
Hokkaido
Site JP81021
Hyōgo
Site JP81022
Hyōgo
Site JP81023
Hyōgo
Site JP81024
Hyōgo
Site JP81025
Hyōgo
Site JP81028
Kagoshima
Site JP81011
Kanagawa
Site JP81012
Kanagawa
Site JP81003
Niigata
Site JP81016
Osaka
Site JP81017
Osaka
Site JP81018
Osaka
Site JP81019
Osaka
Site JP81020
Osaka
Site JP81004
Saitama
Site JP81015
Shizuoka
Site JP81008
Tokyo
Site JP81009
Tokyo
Site JP81010
Tokyo
About this study
Official title: Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)
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.
- Conditions
- Overactive Bladder, Cardiovascular Disease
- Being tested
- Mirabegron
- Keywords
- Mirabegron, Overactive Bladder, Cardiovascular Disease
- Medical subject headings
- Urinary Bladder, Overactive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called YM178, Betanis
oral
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron group | Subjects with overactive bladder and cardiovascular disease prescribed mirabegron Receives: Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in electrocardiogram parameters pre- and post- administration of mirabegron
Measured: Baseline and up to four weeks
Incidence rate of cardiovascular system adverse reactions
Measured: Up to four weeks
Safety assessed by biochemistry laboratory tests
Measured: Up to four weeks
Safety assessed by incidence of adverse events
Measured: Up to four weeks
Secondary outcomes (1)
Changes in overactive bladder (OAB) symptoms
Clinical global impression of change from baseline of OAB symptoms by investigator
Measured: Baseline and up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570035
- Sponsor's protocol ID
- BE0003
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)
- ClinicalTrials.gov ID
- NCT02570035
- Acronym / sponsor ID
- BE0003
- Conditions
- Overactive Bladder, Cardiovascular Disease
- Keywords
- Mirabegron, Overactive Bladder, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirabegron group | – | Drug: MirabegronSubjects with overactive bladder and cardiovascular disease prescribed mirabegron |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- having serious cardiovascular disease
- having significant long QT (QTc > 500 msec)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: YM178, Betanisoral | Drug | Mirabegron group |
Primary outcome
Changes in electrocardiogram parameters pre- and post- administration of mirabegron
Time frame: Baseline and up to four weeks
Incidence rate of cardiovascular system adverse reactions
Time frame: Up to four weeks
Safety assessed by biochemistry laboratory tests
Time frame: Up to four weeks
Safety assessed by incidence of adverse events
Time frame: Up to four weeks
1 secondary outcome
Changes in overactive bladder (OAB) symptoms
Time frame: Baseline and up to four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Cardiovascular Disease, run by Astellas Pharma Inc at 28 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in electrocardiogram parameters pre- and post- administration of mirabegron (time frame: Baseline and up to four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.