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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025060
Receipt No. R000020221
Scientific Title Evaluation of renal blood flow on men who administer tadalafil using contrast-enhanced ultrasound
Date of disclosure of the study information 2016/11/29
Last modified on 2018/02/06

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Basic information
Public title Evaluation of renal blood flow on men who administer tadalafil using contrast-enhanced ultrasound
Acronym Evaluation of renal blood flow on men who administer tadalafil
Scientific Title Evaluation of renal blood flow on men who administer tadalafil using contrast-enhanced ultrasound
Scientific Title:Acronym Evaluation of renal blood flow on men who administer tadalafil
Region
Japan

Condition
Condition healthy patient
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Renal blood flow
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Renal blood flow
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 abdominal echo
Interventions/Control_2
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria healthy patient
Key exclusion criteria medical care
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoei Hara
Organization Kawasaki medical school
Division name Urology
Zip code
Address Matsushima 577, Kurashiki City
TEL 086-462-1111
Email ryoeih@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoei Hara
Organization Kawasaki medical shool
Division name urology
Zip code
Address Matsushima 577, Kurashiki City
TEL 086-462-1111
Homepage URL
Email ryoeih@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki medical shool
Institute
Department

Funding Source
Organization Kawasaki medical shool
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 29 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 29 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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