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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007456
Receipt No. R000008784
Scientific Title Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Date of disclosure of the study information 2012/03/08
Last modified on 2014/09/07

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Basic information
Public title Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Acronym Mechanisms of antiproteinuric effects of AzelnidiPine IN hypertensive patients with type 2 Diabetes Mellitus (MAP in DM)
Scientific Title Mechanisms of antiproteinuric effects of azelnidipine in hypertensive patients with type 2 diabetes mellitus
Scientific Title:Acronym Mechanisms of antiproteinuric effects of AzelnidiPine IN hypertensive patients with type 2 Diabetes Mellitus (MAP in DM)
Region
Japan

Condition
Condition Essential hypertension with type 2 diabetes mellitus and proteinuria
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Strict blood pressure (BP) control as well as inhibition of the renin-angiotensin system (RAS) is essential in the management of hypertensive patients with proteinuria. However, effective BP control is particularly difficult to achieve in patients with diabetes mellitus and target BP levels are seldom achieved with a standard dose of RAS inhibitors. Although calcium channel blockers are frequently used in combination with RAS inhibitors, the blockers have diverse characteristics; some calcium channel blockers, which inhibit N-type or T-type calcium channels, show antiproteinuretic effects similar to those of angiotensin converting enzyme inhibitors. Although azelnidipine, a calcium channel blocker, has been reported to produce potent antiproteinuretic effects, mechanisms underlying the beneficial effect are not clear because the compound has neither N-type nor T-type calcium channel blocking properties. Thus, the present study was designed to examine time-dependent changes in urinary excretion of protein, blood pressure, and several markers of kidney function after the start of treatment with azelnidipine in order to investigate the underlying mechanism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Changes in urinary excretion of albumin from baseline to 1, 2, 4, 12 weeks after randomization
(2) Changes in blood pressure and heart rate from baseline to 1, 2, 4, 12 weeks after randomization
(3) Changes in urine L-FABP, OHdG, sodium, and metanephrine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine
(4) Changes in serum creatinine, hs-CRP, IL-6, ADMA, cystatin C, and pentosidine from baseline to 1, 2, 4, 12 weeks after the treatment with azelnidipine
(5) Relationship of (1) with (2) , (3), (4), (5)
Key secondary outcomes home BP, HbA1c

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and proteinuria are recruited and antihypertensive medications are either started on or switched to a standard dose of an angiotensin receptor blocker (run-in-period). After a 3-month run-in period, baseline evaluations are performed and patients with BP =>130/80mmHg and urinary excretion of albumin =>300mg/g creatinine are enrolled. Then, patients are randomly assigned to receive either azelnidipine (16mg/day) or amlodipine (5mg/day) in combination with a standard dose of an angiotensin receptor blocker for additional 12 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level.
Interventions/Control_2 MAP in DM is a 12-week, prospective, randomized, open, blinded-endpoint (PROBE) study. Type 2 diabetic patients with hypertension and proteinuria are recruited and antihypertensive medications are either started on or switched to a standard dose of an angiotensin receptor blocker (run-in-period). After a 3-month run-in period, baseline evaluations are performed and patients with BP =>130/80mmHg and urinary excretion of albumin =>300mg/g creatinine are enrolled. Then, patients are randomly assigned to receive either azelnidipine (16mg/day) or amlodipine (5mg/day) in combination with a standard dose of an angiotensin receptor blocker for additional 12 months. In cases that the target blood pressure level (<130/80mmHg) is not achieved, increasing doses of an alpha-blocker are prescribed to achieve the target level.
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 diabetic patients with essential hypertension and proteinuria are recruited and are either started on or switched to a monotherapy with a standard dose of an angiotensin receptor blocker for 3 months (run-in -period). Patients with BP =>130/80 mmHg and urinary excretion of albumin =>300mg/g creatinine at the end of run-in-period are finally enrolled.
Key exclusion criteria Exclusion criteria are: secondary hypertension; history of acute coronary syndrome, heart failure, coronary revascularization, or stroke within the previous 6 months; uncontrolled diabetes mellitus (HbA1c >9.0%); confirmed or suspected renal artery stenosis; serum creatinine of 1.5mg/dl or more for men and 1.2mg/dl or more for women; contraindication to calcium channel blockers; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.
Target sample size 30

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 Masayoshi Kojima
Organization Komono Kosei Hospital
Division name Department of Internal Medicine
Zip code
Address 75 Fukumura, Komono-cho, Mie
TEL 059-393-1212
Homepage URL
Email m-kojima@kkh.miekosei.or.jp

Sponsor
Institute Komono Kosei Hospital
Institute
Department

Funding Source
Organization Nagoya City university Graduate School of Medical Sciences
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 08 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
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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 06 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=R000008784

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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