UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005034 |
|---|---|
| Receipt number | 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 18:33:01 |
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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
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
nnoozaki@kumamoto-u.ac.jp
Sponsor or person
Institute
Seigo Sugiyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005986
