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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000930
Receipt No. R000001052
Scientific Title Secondary Protective effect of ca-antagonist for ischemic heart attack randominzed parallel comparison with beta-blocker trial
Date of disclosure of the study information 2007/12/04
Last modified on 2009/06/12

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Basic information
Public title Secondary Protective effect of ca-antagonist for ischemic heart attack
randominzed parallel comparison with beta-blocker trial
Acronym SPECIAL
Scientific Title Secondary Protective effect of ca-antagonist for ischemic heart attack
randominzed parallel comparison with beta-blocker trial
Scientific Title:Acronym SPECIAL
Region
Japan

Condition
Condition Ischemic heart disease (post-myocardila infarction angina, angina pectoris)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.To clarify the differences of protective effects on cardiovascular events between atenolol and benidipine.
2.To clarify protective effects of benidipine in the patients with vasospastic angina.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes cardiovascular evetns including myocardial infarction, angina, silent myocardial ischemia, taget lesion revascularization, cerebral infarction, intracerebral hemorrhage
Key secondary outcomes 1. all death
2. hospitalization due to heart failure etc
3. renal failure (hemodialysis)

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 considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 atenolol-treated group

dose: 50 mg QD
maximum dose: 100mg
Permission to change the dose according to age or symptoms.
Interventions/Control_2 benidipine-treated group

dose: 4mg BID

Permission to change the dose according to age or symptoms.
Interventions/Control_3 vasospastic angina patient group

benidipine dose: 4mg BID

Permission to change the dose according to age or symptoms.
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. post-myocardial angina
healed myocardial infarction or
>1 month after acute
myocardial infarction under stable
conditions
2. angina pectoris
>=1mm ST deviation on chest pain was observed and coronary angiography within 6 months revealed 75%<= stenosis
Vasospasm
Acetylcholineor ergonobin induced vasospasm, catheter-induced vasospasm, or 1mm<= ST elevation on chest pain
Key exclusion criteria 1) previous history of hypersensitivity or intolerance of atenolol or benidipine
2) cardiogenic shock
3)diabetic ketoacidosis, metabolic acidosis
4)severe or symptomatic bradycardia, atrioventricular block (II, III degree), sinoatrial block, sick sinus syndrome
5)critical arrhythmia
6)right ventricular failure with pulmonary hypertension
7)congestive heart failure
8)hypotension
9)severe peripheral arterial disease (gangrene etc)
10)untreated pheochromocytoma
11)any women who is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
12)severe hepatic failure (total bilirubin >2.0mg/dL)
13)severe renal failure (serum creatinin >3.0mg/dL)
14)infection, paralytic or obstractive ileus
15)ongoing or planning treatment with anti-cancer drugs
16)other serious illness or significant abnormalities that the investigator judges inappropriate for the study
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruo Takano
Organization Nippon Medical School
Division name Department of Internal Medicine, division of cardiology
Zip code
Address 1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Mizuno
Organization Nippon Medical School
Division name Department of Internal Medicine, division of cardiology
Zip code
Address 1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School, Department of Internal Medicine, division of cardiology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nippon Medical School, Chiba Hokusoh hospital, Musashi Kosugi hospital, Tama Nagayama hospital
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
2007 Year 12 Month 04 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 Completed
Date of protocol fixation
2001 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2002 Year 07 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 04 Day
Last modified on
2009 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001052

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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