UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001762 |
|---|---|
| Receipt number | 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 13:11:36 |
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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
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
hiyamada@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002122
