UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001152 |
|---|---|
| Receipt number | 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 10:33:19 |
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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
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/
cope-2@yamaguchi-u.ac.jp
Sponsor or person
Institute
COPE Trial Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001398
