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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name