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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008325
Receipt No. 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

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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
Email 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
Email ishida@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007891

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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