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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001762
Receipt No. R000002122
Scientific Title Effects of Telmisartan compared with Candesartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial
Date of disclosure of the study information 2009/04/01
Last modified on 2014/09/09

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Basic information
Public title Effects of Telmisartan compared with Candesartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial
Acronym Effects of Telmisartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial
Scientific Title Effects of Telmisartan compared with Candesartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial
Scientific Title:Acronym Effects of Telmisartan on ischemic cardiovascular events in high-risk hypertensive patients: a multi-center, prospective, randomized, open-labeled, blinded endpoints trial
Region
Japan

Condition
Condition Essential hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether treatment with Telmisartan is more effective than Candesartan on reducing the ischemic cardiovascular events in high-risk hypertensive patients.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes New or recurrent acute myocardial infarction, angina pectoris, and asymptomatic myocardial ischemia
Key secondary outcomes All causes of mortality, cardiovascular death (myocardial infarction, stroke, aortic dissection, aortic rupture, etc.)
New or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Telmisartan treatment
Interventions/Control_2 Candesartan treatment
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
85 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria are set by at least one of the three following risk factors:

1)Coronary artery disease documented by at least one of the following:
1.Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
2.Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

2)Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment

3)Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment
Key exclusion criteria The exclusion criteria are set as follow:
1. History of worsening of heart failure within the preceding 6 months
2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
5. History of cerebral infarction, cerebral hemorrhage within the past 6 months
6. Congenital heart disease
7. Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg)
8. Pregnant women or women of childbearing potential
9. Hepatic dysfunction (AST or ALT >100IU/L)
10. Renal impairment (serum creatinine level >2.0 mg per 100 ml)
11. Known hypersensitivity or intolerance to ARB
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsubara
Organization Kyoto Prefectural University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Yamada
Organization Kyoto Prefectural University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5511
Homepage URL https://evd.captool.jp/MBX/BaseTool/TrialSpotGate/KCPS
Email hiyamada@koto.kpu-m.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 04 Month 01 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
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 Terminated
Date of protocol fixation
2008 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 10 Month 31 Day
Date analysis concluded
2014 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 09 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002122

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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