UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000331 |
|---|---|
| Receipt number | R000000423 |
| Scientific Title | The protective effects of Telmisartan on the cardiovascular system |
| Date of disclosure of the study information | 2006/02/21 |
| Last modified on | 2019/02/05 09:48:59 |
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Basic information
Public title
The protective effects of Telmisartan on the cardiovascular system
Acronym
The protective effects of Telmisartan on the cardiovascular system
Scientific Title
The protective effects of Telmisartan on the cardiovascular system
Scientific Title:Acronym
The protective effects of Telmisartan on the cardiovascular system
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pleiotropic effects except for anti-hypertensive effect of Telmisartan on cardiovascular systems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressure, cardiovascular clinical event,cardiac hypertrophy, cardiac function, atherosclerosis,insulin resistance, renal function
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with Telmisartan
Interventions/Control_2
treatment with Losartan
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertension patient
Key exclusion criteria
*Secondary hypertension
*heart failure
*diabetes mellitus
*acute myocardial infarction within 6 months
*treated with PCI within 6 months
*cerebrovascular disease within 3 months
*severe renal failure (serum creatinine>3mg/dl
*severe hepatic failure
*malignant disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hasegawa |
Organization
Chiba University Graduate School of Medicine
Division name
Cardiovascular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432227171
hasegawa-chiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hasegawa |
Organization
Chiba University Graduate School of Medicine
Division name
Cardiovascular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432227171
Homepage URL
hasegawa-chiba@umin.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science, Sports, and Culture
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2006 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2005 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | 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
| 2006 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000423
