UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005034
Receipt No. R000005986
Scientific Title The effect of telmisartan on endothelial function in hypertensive patients.
Date of disclosure of the study information 2011/02/20
Last modified on 2013/09/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of telmisartan on endothelial function in hypertensive patients.
Acronym The effect of telmisartan on endothelial function.
Scientific Title The effect of telmisartan on endothelial function in hypertensive patients.
Scientific Title:Acronym The effect of telmisartan on endothelial function.
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effect of telmisartan in hypertensive patietns with endothelial dysfunction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endothelial function assessed by digital assessment of reactive hyperemia peripheral arterial tonometry (RH-PAT).
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Exchnage ARBs except for telmisartan to telmisartan
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 Inclusion criteria were age between 20 and 80 years, stable patients who took angiotensin II type 1 receptor blockers (ARBs) except for telmisartan, patients who had endothelial dysfunction assessed by digital assessment of reactive hyperemia peripheral arterial tonometry (RH-PAT).We enrolled patients with RH-PAT values less than 1.80 as endothelial dysfunction.
Key exclusion criteria Patients with RH-PAT values over 1.80.
Un-controlable hypertension.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimitsu Nozaki
Organization Faculty of Life Sciences, Graduate School of Medical Science, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto city, Japan
TEL 096-373-5175
Email nnoozaki@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimitsu Nozaki
Organization Faculty of Life Sciences, Graduate School of Medical Science, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto city, Japan
TEL 096-373-5175
Homepage URL
Email nnoozaki@kumamoto-u.ac.jp

Sponsor
Institute Seigo Sugiyama
Institute
Department

Funding Source
Organization This study was supported in part by grants-in-aid for Scientific Research (#C19590869 for S. Sugiyama) from the Ministry of Education, Science, and Culture, Japan
Organization
Division
Category of Funding Organization Non profit foundation
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
2011 Year 02 Month 20 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 Completed
Date of protocol fixation
2009 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 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
2011 Year 02 Month 05 Day
Last modified on
2013 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.