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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003195
Receipt No. R000003862
Scientific Title Clinical study on the resistance to antihypertensive therapy in patients with diabetes mellitus
Date of disclosure of the study information 2010/02/17
Last modified on 2010/02/16

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Basic information
Public title Clinical study on the resistance to antihypertensive therapy in patients with diabetes mellitus
Acronym CORE-AT-DM
Scientific Title Clinical study on the resistance to antihypertensive therapy in patients with diabetes mellitus
Scientific Title:Acronym CORE-AT-DM
Region
Japan

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

Objectives
Narrative objectives1 Individuals with hypertension and diabetes mellitus carry a dramatically increased cardiovascular risk. Although data from clinical studies emphasize the benefit from aggressive blood pressure control, effective blood pressure control can be particularly difficult to be achieved in such patients. In order to perform beneficial management of patients with hypertension and diabetes mellitus, it is worth identifying factors that build up resistance to the antihypertensive attack. Thus, we investigated factors associated with resistance to antihypertensive therapy in patients with hypertension and diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint is the number of antihypertensive medications needed per patient to achieve the target home blood pressure goal. The step number of antihypertensive medication where the target blood pressure is achieved is considered as the number of antihypertensive medications needed for blood pressure control.
Key secondary outcomes (1) The average reduction of self-measured home blood pressure caused by a single mdication step in each patient calculated by the following equation: (baseline blood pressure) - (achieved blood pressure) / the step number where target blood pressure is achieved.
(2) Self-measured blood pressure at home
(3) Clinic blood pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are instructed to perform measurements of blood pressure every day within 1 hour of waking, after urination, after 1-2 min rest in a seated position, before taking antihypertensive drugs, and before breakfast in the morning, according to the Japanese guideline using a semi-automated device with a memory capacity. After a baseline evaluation, upward-titration of medication is implemented without a placebo run-in period in 8 steps (each step for 8 weeks) to reach a target home blood pressure of <130/80mmHg: step 1, routine dose of angiotensin receptor blocker (ARB); step 2, routine doses of ARB and calcium channel blocker (CCB); step 3, step1 + double dose of CCB; step 4, double doses of ARB and CCB; step 5, step 4 + routine dose of diuretic; step 6, step 5 + routine dose of beta-blocker; step 7, step 6 + routine dose of alpha-blocker; step 8, step 6 + double dose of alpha-blocker. The average of self-measured blood pressure for consecutive 7 days at baseline and at the end of each step is used for evaluation. Routine doses of antihypertensive drugs prescribed are olmesartan 20mg, telmisartan 40mg, candesartan 8mg, valsartan 80mg (ARB); long acting nifedipine 40mg, amlodipine 5mg, benidipine 4mg (CCB); trichrolothiazide 2mg, indapomide 1mg (diuretic); bisoprolol 5mg, atenolol 50mg (beta-blocker); and doxazosine 2mg (alpha-blocker). If clinic systolic and/or diastolic blood pressure exceeds the safety parameters of 180mmHg and/or 105mmHg, respectively, at any point, hypertensive medication will be immediately titrated to the next step.
Interventions/Control_2
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
25 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Hypertensive patients with type 2 diabetes mellitus who are not being treated for hypertension
Key exclusion criteria Exclusion criteria are: secondary hypertension; history of myocardial infarction, heart failure, angina pectoris, or stroke; uncontrolled diabetes mellitus (HbA1c >9.0%); a disorder that required treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, diuretics, or beta-blockers; renal artery stenosis; serum creatinine of 2.0mg/dl or more; pregnant women; or clinic systolic blood pressure >200mmHg and/or diastolic blood pressure >110mmHg.
Target sample size 100

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Komono Kosei Hospital
Division name Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Komono Kosei Hospital
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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 17 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 Completed
Date of protocol fixation
2005 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 16 Day
Last modified on
2010 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003862

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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