UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003195 |
|---|---|
| Receipt number | 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 13:12:59 |
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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
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
Sponsor or person
Institute
Komono Kosei Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003862
