UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007463 |
|---|---|
| Receipt number | R000008780 |
| Scientific Title | Combination effects of an angiotensin receptor blocker and an L/T type calcium channel blocker in hypertensive patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2012/03/07 |
| Last modified on | 2014/09/07 21:23:32 |
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Basic information
Public title
Combination effects of an angiotensin receptor blocker and an L/T type calcium channel blocker in hypertensive patients with type 2 diabetes mellitus
Acronym
COmbination Effects of an angiotensin receptor blocker and an L/T type calcium chaNnel blocker in hypertensive patients with type 2 diabetes mellitus (COEN)
Scientific Title
Combination effects of an angiotensin receptor blocker and an L/T type calcium channel blocker in hypertensive patients with type 2 diabetes mellitus
Scientific Title:Acronym
COmbination Effects of an angiotensin receptor blocker and an L/T type calcium chaNnel blocker in hypertensive patients with type 2 diabetes mellitus (COEN)
Region
| Japan |
Condition
Condition
Essential hypertension with type 2 diabetes mellitus and albuminuria
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inhibition of the renin angiotensin system is essential in the management of hypertensive patients with albuminuria. However, the next step of medication for further reduction in blood pressure and urinary albumin has not been established. The present study was designed to compare effects of additional treatment with benidipine versus amlodipine on urinary excretion of albumin in hypertensive patients with type 2 diabetes and albuminuria under treatment with angiotensin receptor blockers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in urinary excretion of albumin from baseline to 12 months after randomization
Key secondary outcomes
1. Changes in blood pressure and pulse rate
2. Changes in serum creatinine and glomerular filtration rate
3. Changes in NT-pro BNP and CRP
4. Correlation of changes in urinary excretion of albumin with other secondary outcomes
5. Adverse Effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
COEN is a 12-month, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and albuminuria under a monotherapy with an angiotensin receptor blocker are screened for the eligibility for the present study. Patients with urinary excretion of albumin =>10mg/g creatinine and blood pressure =>130/80mmHg are enrolled. Then, patients are randomly assigned to receive either benidipine (4mg/day) or amlodipine (5mg/day) in addition to an angiotensin receptor blocker for 12 months.
Interventions/Control_2
Patients are randomly assigned to receive either benidipine (4mg/day) or amlodipine (5mg/day) in addition to an angiotensin receptor blocker for 12 months.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
Essential hypertension
Urinary excretion of albumin =>10mg/g creatinine and office systolic blood pressure =>130mmHg and/or diastolic blood pressure =>80mmHg under a monotherapy with a standard dose of angiotensin recptor blockers
Key exclusion criteria
Previous acute coronary syndrome, myocardial infarction, or stroke within 6 months; malignant neoplasm; heart failure (=>NYHA 2); peripheral artery disease (=>Fontaine 2); chronic inflammatory disease; hepatic disorder; estimated glomerular filtration rate <30 ml/min/1.73m2; contraindication to calcium channel blockers
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kojima |
Organization
Komono Kosei Hospital
Division name
Department of Internal Medicine
Zip code
Address
75 Fukumura, Komono-cho, Mie
TEL
059-393-1212
m-kojima@kkh.miekosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Dohi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal Medicine and Hypertension
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8221
Homepage URL
ydohi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
菰野厚生病院（三重県）
遠州総合病院（静岡県）
Komono Kosei Hospital (Mie)
Enshu Hospital (Shizuoka)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 07 | Day |
Last modified on
| 2014 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008780
