UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005541 |
|---|---|
| Receipt number | R000006572 |
| Scientific Title | Aggressive antihypertensive treatment for protecting cardiovascular complications in pre-diabetic hypertensive patients |
| Date of disclosure of the study information | 2011/05/02 |
| Last modified on | 2013/11/02 12:06:20 |
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Basic information
Public title
Aggressive antihypertensive treatment for protecting cardiovascular complications in pre-diabetic hypertensive patients
Acronym
APPROACH trial
Scientific Title
Aggressive antihypertensive treatment for protecting cardiovascular complications in pre-diabetic hypertensive patients
Scientific Title:Acronym
APPROACH trial
Region
| Japan |
Condition
Condition
1.Hypertensive patients with diabetes mellitus (DM), pre-diabetes: DM was defined as at least one of the following criteria: fasting blood glucose >=126mg/dl, 2-hour glucose in 75gOGTT >=200mg/dl, HbA1c >=6.1%, or treated diabetes.Pre-diabetes was diagnosed as HbA1c >=5.7%
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the successful control rate of BP, the change of the measure of target organ damage, and adverse effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BP control rate: the percentage of attaining target home BP <125/75mmHg
Key secondary outcomes
BP: BP control rate and the degree of BP lowering at the end of the treatment
Renal function: the changing rate of serum creatinine (eGFR) and urinary microalbumin
Diabetes: changing rate of HbA1c and fasting blood glucose
Pulse wave velocity (PWV)
Augmentation index at radial artery
Baroreflex sensitivity (BRS)
Flow mediated dilatation (FMD)
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
Increase the dose of the drug.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hypertension with dibetes mellitus or pre-diabetes.
2. Morning systolic blood pressure >=135 with self-monitoring BP at home
3. The age >=30 years
4. The patients were either never treated, single drug therapy (CCB or ACE-I, ARB), or double drug therapy in combination with CCB plus ACE-I, ARB.
Key exclusion criteria
1. Secondary hypertension
2. Patients with congestive heart failure, acute MI less than 6months, acute stroke less than 6months, atrial fibrilation, AV block, or significant arrhythmia.
3.Hepatic damage (AST, ALT >twice of upper limits, renal dysfunction (serum creatine
4. Allergy, or allergic reaction
5. Dementia from whom we cannot obtain informed consent.
6. pregnancy
7. for whom the attending doctor considerd he or she is not appropriate for the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Departmentof Medicine
Zip code
Address
3311-1 Yakusiji,Shimotsuke, Tochigi 329-0498, Japan
TEL
0285-58-7344
ke112@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Departmentof Medicine
Zip code
Address
3311-1 Yakusiji,Shimotsuke, Tochigi 329-0498, Japan
TEL
0285-58-7344
Homepage URL
ke112@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
International University of Health and Welfare Hospital
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
自治医科大学付属病院
国際医療福祉大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 02 | 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
| 2009 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 02 | Day |
Last modified on
| 2013 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006572
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| Registered date | File name |
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| Registered date | File name |
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