UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014248 |
|---|---|
| Receipt number | R000016556 |
| Scientific Title | Study of PPAR-gamma activating effect of angiotensin II receptor antagonist, telmisartan |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2021/07/27 17:05:29 |
* 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
Study of PPAR-gamma activating effect of angiotensin II receptor antagonist, telmisartan
Acronym
PPAR-gamma activating effect of angiotensin II receptor antagonist
Scientific Title
Study of PPAR-gamma activating effect of angiotensin II receptor antagonist, telmisartan
Scientific Title:Acronym
PPAR-gamma activating effect of angiotensin II receptor antagonist
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether telmisartan more increases sRAGE concentration in blood compared to olmesartan
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An increase of sRAGE concentration in blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
# Telmisartan, 20mg/day
# Dose will be increased (MAX 80mg/day) until clinical blood pressure is lowered less than 140/90 mmHg.
# Six months
Interventions/Control_2
# Olmesartan, 10mg/day
# Dose will be increased (MAX 40mg/day) until clinical blood pressure is lowered less than 140/90 mmHg.
# Six months
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
1) Hypertensive patients who were either never treated or treated with amlodipine alone
2) More than two months without any change in treatment, including amlodipine
3) All concomitant disease are stable
4) Patients who can give written informed consent
Key exclusion criteria
1) Patients treated with Ca-channel blockers (excluded amlodipine), ARB, angiotensin converting enzyme inhibitors, statin, anti-diabetic drugs, beta-blockers or thiazide diuretics
2) Patients with hypersensitivity to the drug contents
3) Pregnant women
4) Patients with severe renal dysfunction
5) Patients with secondary hypertension
6) Patients who are disqualified by the doctor
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Fujimura |
Organization
Jichi Medical University
Division name
Division of Clinical Pharmacology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7388
akiofuji@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ushijima |
Organization
Jichi Medical University
Division name
Division of Clinical Pharmacology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7388
Homepage URL
ushijima-kentarou@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Section
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-7550
rinri@jichi.ac.jp
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
| 2014 | Year | 06 | Month | 12 | 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
43
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
| 2014 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016556
