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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001152
Receipt No. R000001398
Scientific Title Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial
Date of disclosure of the study information 2008/05/12
Last modified on 2015/03/24

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Basic information
Public title Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial
Acronym COPE Trial
Scientific Title Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial
Scientific Title:Acronym COPE Trial
Region
Japan

Condition
Condition Outpatients who are required a
combination therapy with sitting
systolic blood pressure
>=140 mmHg or diastolic blood
pressure>=90 mmHg
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to directly compare cardiovascular mortality and morbidity,
incidence of adverse drug reaction, and degree of blood pressure reduction in Japanese hypertensive patients for a combination of angiotensin receptor blockers, beta-blockers or thiazide diuretics in addition to a calcium antagonist, benidipine hydrochloride, with a response-dependent dose titration scheme
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1)A composite of fatal and non-fatal cardiovascular events
(1)Sudden death (acute onset and intrinsic death within 24 h)
(2)Fatal or nonfatal stroke (new onset or recurrence)
(3)Fatal or nonfatal myocardial infarction (new onset or recurrence), hospitalization due to unstable angina, new onset of heart failure(Class II, III, or IV), sudden cardiac death
(4)New onset or worsening of peripheral arterial disease
(5)New onset or worsening of renal failure(as indicated by a serum creatinine level that is at least doubled to over 2 mg/dl) serum creatinine >=4.0 mg/dl, renal dialysis or renal transplantation
2)Achievement of target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg)serious and non-serious cardiovascular events
Key secondary outcomes (1) All-cause mortality
(2) Death from cardiovascular events
(3) Fatal and non-fatal cardiovascular events
(4) Hospitalization due to heart failure
(5) New onset of diabetes mellitus
(6) Safety (adverse events and adverse drug reaction)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 benidipine + angiotensin receptor blocker
Interventions/Control_2 benidipine + beta-blocker
Interventions/Control_3 benidipine + thiazide diuretic
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
40 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1.Outpatients who are required a combination therapy with sitting systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg
2. Outpatients aged over 40 years and less than 85 years (inclusive),regardless of sex
3. Previously untreated patients or patients who are on other therapy, which can be converted to 4 mg of benidipine
4. Patients who can be treated with benidipine, angiotensin receptor blockers,beta-blockers, and thiazide diuretics
Key exclusion criteria 1. Seated systolic blood pressure >=200 mmHg or seated diastolic blood pressure >=120 mmHg
2. Secondary hypertension
3. Type 1 diabetes mellitus or type 2 diabetes on insulin treatment
4. History of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study
5. Heart failure (NYHA functional classification II, III or IV)
6. Congenital heart disease or a history of rheumatic heart disease
7. Chronic atrial fibrillation or atrial flutter
8 Serious liver dysfunction (AST or ALT >=100 IU/l) or Serious renal dysfunction (serum creatinine >=2 mg/dl)
9. Severe peripheral arterial disease (Fontaine Class II, III or IV)
10. History of malignancy 5 years prior to study entry
11. Pregnancy
12. Compliance rate <70% assessed by a patient interview
13. Known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers,beta-blockers, and thiazide diuretics
14. Other serious illness or significant abnormalities that the investigator judges inappropriate for the study
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Ogihara
Organization Osaka University Graduate School of Medicine
Division name Department of Geriatric Medicine
Zip code
Address 2-2 Yamada-oka,Suita,Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Umemoto
Organization Yamaguchi University
Division name Phamaceutical Clinical Research center
Zip code
Address 1-1-1 Minamikogushi,Ube,Yamaguchi
TEL 0836-85-3101
Homepage URL http://ds.cc.yamaguchi-u.ac.jp/
Email cope-2@yamaguchi-u.ac.jp

Sponsor
Institute COPE Trial Group
Institute
Department

Funding Source
Organization Kyowa Hakko Kogyo Co.,
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Japanese Society of Hypertension
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00135551
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 12 Day

Related information
URL releasing protocol http://www.jstage.jst.go.jp/article/hypres/28/4/28_331/_article
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
2002 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 12 Day
Last modified on
2015 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001398

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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