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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007463
Receipt No. 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

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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
Email 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
Email ydohi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008780

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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