UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The protective effects of Telmisartan on the cardiovascular system
Title of the study (Brief title)	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	Hiroshi Hasegawa
Organization	Chiba University Graduate School of Medicine
Division name	Cardiovascular Science and Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	0432227171
Email	hasegawa-chiba@umin.ac.jp

Public contact
Name of contact person	Hiroshi Hasegawa
Organization	Chiba University Graduate School of Medicine
Division name	Cardiovascular Science and Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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