UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011998 |
|---|---|
| Receipt number | R000014025 |
| Scientific Title | Efficacy and safety of imidafenacin in female overactive bladder patients with hypertension. |
| Date of disclosure of the study information | 2013/10/15 |
| Last modified on | 2013/10/09 14:28:18 |
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Basic information
Public title
Efficacy and safety of imidafenacin in female overactive bladder patients with hypertension.
Acronym
Efficacy and safety of imidafenacin in female overactive bladder patients with hypertension.(East Noah Study)
Scientific Title
Efficacy and safety of imidafenacin in female overactive bladder patients with hypertension.
Scientific Title:Acronym
Efficacy and safety of imidafenacin in female overactive bladder patients with hypertension.(East Noah Study)
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of imidafenacin in female overactive patients with or without hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overactive bladder symptom score
Key secondary outcomes
frequency volume chart, Athens Insomnia Scale Actigram, Nocturia Quality-of-Life Questionnare, adverse effects, patient background, uroflowmetry, residual urine volume
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of imidafenacin
Interventions/Control_2
hypertension
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
overactive bladder patients and whose OABSS Q2 score is over 2 and Q3 is over 2
Key exclusion criteria
stress urinary incontinence patient, patient who have urinary dysfunction, allergy for anticholinergic agents
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Kouchi |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Urology
Zip code
Address
Kawadacho 8-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
ykouchi@kc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Kouchi |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Urology
Zip code
Address
Kawadacho 8-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
ykouchi@kc.twmu.ac.jp
Sponsor or person
Institute
Department of Urology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2013 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014025
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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