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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002088
Receipt No. R000002549
Scientific Title Effect of candesartan on recurrence of esophageal varices after endoscopic therapy with hypertenton
Date of disclosure of the study information 2009/06/17
Last modified on 2017/02/21

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Basic information
Public title Effect of candesartan on recurrence of esophageal varices after endoscopic therapy with hypertenton
Acronym Effect of candesartan on recurrence of esophageal varices after endoscopic therapy with hypertenton
Scientific Title Effect of candesartan on recurrence of esophageal varices after endoscopic therapy with hypertenton
Scientific Title:Acronym Effect of candesartan on recurrence of esophageal varices after endoscopic therapy with hypertenton
Region
Japan

Condition
Condition esophageal varices
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare the effectiveness of prevention of recurrence using candesartan or carsium blocker after endoscopic therapy for esophageal veaces with hypertention
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ratio of rcurrence of esophageal veaces
and bleeding
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of candesartan for esophageal varices
Interventions/Control_2 Administration of carcium blocker for esophageal varices
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will undergo endoscopic therapy for wsophageal varices with hypertention
Key exclusion criteria Patients who take beta-blocker, nitrates or angiotensin receptor antagonist
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Imaeda, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3600
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Imaeda, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3600
Homepage URL
Email

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department

Funding Source
Organization Takeda Parmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 06 Month 17 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 17 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002549

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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