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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000331
Receipt No. 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

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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
Email 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
Email hasegawa-chiba@umin.ac.jp

Sponsor
Institute Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000423

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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