UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008325 |
|---|---|
| Receipt number | R000007891 |
| Scientific Title | Effect of T/L-type calcium channel blockers on serum biomarkers for cardiovascular function |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2016/01/04 17:11:42 |
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Basic information
Public title
Effect of T/L-type calcium channel blockers on serum biomarkers for cardiovascular function
Acronym
BAM-Kobe Study
Scientific Title
Effect of T/L-type calcium channel blockers on serum biomarkers for cardiovascular function
Scientific Title:Acronym
BAM-Kobe Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of T/L type calcium channel blockers on blood pressure, serum renin-angiotensin-aldosteron system, and cardiovascular functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure, serum lipid profile, electrites, endocrinological profile
Key secondary outcomes
left ventricular mass, cardiovascular function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
benidipine
Interventions/Control_2
amlodipine
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
The study participants, aged over 30 years, were recruited by physicians from Kobe University Graduate School of Medicine. The entry period was from December 2011 to December 2013. We enrolled consecutive hypertensive outpatients whose BP had been uncontrolled without any anti-hypertensive drugs or with usual-dose of ARBs alone at least 4 weeks.
This study is a prospective, randomized, open-label, comparative multicenter study. Eligibile patients were randomly assigned to switch to a therapy with benidipine 8mg/day or with 5mg amlodipine. The primary outcome was the change in office BP from baseline value at 12 and 24 weeks. Therapeutic target levels of office BPs were 130/85 mmHg for patients aged less than 64 years, 140/90 mmHg for patients aged 65 years or more, and 130/80 mmHg for patients with diabetes mellitus and/or chronic kidney disease as defined by the 2009 JSH guidelines. Clinic BPs were measured by the auscultation method using a mercury sphygmomanometer during rest in a seated position. BPs at home were measured using an automatic digital sphygmomanometer. The self-monitoring of morning BP was made within 1-hour after waking, before taking antihypertensive drugs. The mean pressure was calculated as diastolic blood pressure plus one-third of pulse pressure. Patients whose diastolic BP reached under 90 mmHg or decreased from the baseline value by 10 mmHg at 12 weeks were defined as responders. Throughout the study, lipid-lowering, anti-diabetic, or uricosuric drug regimens were continued without changing their dose or usage.
Key exclusion criteria
Patients with severe uncontrolled hypertension (diastolic BP over 110 mmHg), secondary hypertension, hyperuricemia, a past history of gout attack, poorly controlled [glycated hemoglobin A1c (HbA1C over 8.0] or insulin-treated diabetes mellitus, cardiovascular events including myocardial infarction and stroke within the preceding 3 months, severe liver dysfunction, renal failure (serum creatinine over 2.0 mg/dL), active malignancy, pregnancy, severe bile dysfunction, or allergy to benidipine or amlogipin were excluded from the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishida |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
ishida@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuro Ishida |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
Homepage URL
ishida@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe University 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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007891
