UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021594 |
|---|---|
| Receipt number | 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 22:27:46 |
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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
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
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023574
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