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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021594
Receipt No. R000023574
Scientific Title An increase dose of CCB or ARB as an add-on intensive DEpressor therapy in type 2 diabetes MellItus patients with uncontrolled Essential hypertension.
Date of disclosure of the study information 2016/03/24
Last modified on 2019/02/07

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Basic information
Public title An increase dose of CCB or ARB as an add-on intensive DEpressor therapy in type 2 diabetes MellItus patients with uncontrolled Essential hypertension.
Acronym Intensive depressor therapy in diabetes mellItus patients with hypertension (ACADEMIE Study)
Scientific Title An increase dose of CCB or ARB as an add-on intensive DEpressor therapy in type 2 diabetes MellItus patients with uncontrolled Essential hypertension.
Scientific Title:Acronym Intensive depressor therapy in diabetes mellItus patients with hypertension (ACADEMIE Study)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patients with type 2 diabetes mellitus who do not reach target blood pressure (BP), although they have received combination therapy with middle doses of calcium channel blocker (CCB) and angiotensin type 1 receptor blocker (ARB), are enrolled. They receive an increase dose of CCB or ARB as an add-on intensive depressor therapy, and the differential depressor effect between the two kinds of therapies are analyzed. In addition, the differential effects of renal protection and anti-inflammation between the two groups are also examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in home systolic BP early in the morning between at baseline and after 12 weeks
Key secondary outcomes Changes in various parameters between at baseline and after 12 weeks as follows (No. 1-14):
1.Home diastolic BP early in the morning
2.Office BP
3.Home BP before going to the bed
4.Home BP in sleeping
5.Percentage of the patients who reach the target BP (Office BP and BP early in the morning)
6.Variability and coefficient of BP
7.Brachial-ankle pulse wave veocity
8.High-sensitivity C reactive protein
9.Pentraxin-3
10.Adiponectin
11.Brain natriuretic peptide
12.Urinary albumin
13.Cystatin C
14.L-FABP
15.Side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients with hypertension under treatment with middle dose of ARB + amlodipine 5 mg/day are enrolled. The patients receive a middle dose of ARB + amlodipine 10 mg/day and treated for 12 weeks.
Interventions/Control_2 The patients with hypertension under treatment with middle dose of ARB + amlodipine 5 mg/day are enrolled. The patients receive a high dose of ARB + amlodipine 5 mg/day and treated for 12 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with diabetes mellitus according to the Japan Diabetes Society guideline
2.Patients with essential hypertension who had SBP = or > 130 mmHg and/or DBP = or > 80 mmHg and received a middle dose of ARB + amlodipine 5 mg/day at least for 4 weeks.
3.Age is 20 years old or more.
4.Patients who gave their informed consent to participate for the present study.
Key exclusion criteria 1.The patients with secondary hypertension
2.The patients who had SBP < 130 mmHg and DBP < 80 mmHg before starting the study
3.Severe liver dysfunction.
4.Severe renal dysfunction.
5.Pregnancy or lactation in women.
6.Patients with a history of allergy to any component of the study medications.
7.Patients corresponding to the contraindication of study medications.
8.Participating in other clinical trials or within 3 months after retirement of prior clinical trial,
9.Ineligible based on the judgment of the physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University Hospital
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Email miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University Hospital
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Homepage URL
Email miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute Department of Cardiology, Fukuoka University Hospital
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 福岡大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 24 Day

Related information
URL releasing protocol
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
2016 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 24 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
2016 Year 03 Month 24 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023574

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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