UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025949 |
|---|---|
| Receipt number | R000029831 |
| Scientific Title | Feasible study of the effect of irbesartan on psoriasis |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/02/01 13:36:27 |
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Basic information
Public title
Feasible study of the effect of irbesartan on psoriasis
Acronym
The effect of irbesartan on psoriasis
Scientific Title
Feasible study of the effect of irbesartan on psoriasis
Scientific Title:Acronym
The effect of irbesartan on psoriasis
Region
| Japan |
Condition
Condition
psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of Irbesartan, an antihypertensitive drug, on psoriasis patients complicated with hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of PASI three months after the start of Irbesartan
Key secondary outcomes
Assessment of PDI three months after the start of Irbesartan
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration period is three months. Dosage of irbesartan is 100mg.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Psoriasis patients with hypertension
Key exclusion criteria
Minors or adults of imcomplete judgement
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetosgi Sano |
Organization
Kochi Medical School
Division name
Department of Dermatology
Zip code
Address
Kohasu, Okohcho, Nankoku, Kochi
TEL
0888802363
sanoderma@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nakajima |
Organization
Kochi Medical School
Division name
Department of Dermatology
Zip code
Address
Kohasu, Okohcho, Nankoku, Kochi
TEL
0888802363
Homepage URL
nakajima@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 10 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029831
