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

* 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

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 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


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

Value
https://center6.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