UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between amlodipine and benidipine on prognosis among patients after hypertensive heart failure
Acronym	Amlodipine or benidipine after hypertensive heart failure
Scientific Title	Comparison between amlodipine and benidipine on prognosis among patients after hypertensive heart failure
Scientific Title:Acronym	Amlodipine or benidipine after hypertensive heart failure
Region	Japan

Condition
Condition	hypertensive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of amlodipine and benidipine as a second prevention drug for hypertensive heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrent rate of hospitalization due to heart failure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Amlodipine
Interventions/Control_2	Benidipine
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Systolic blood pressure was above 160 mmHg with acute pulmonary edema when hospitalized. 2. above 20 y.o. and below 80 y.o. 3. Able to take oral medicine. 4. a. Systolic blood pressure is above 130 mmHg or diastolic blood pressure is above 80 mmHg. or, b. Continuing drip injection of calcium channel blocker. 5. Able to understand informed consent.
Key exclusion criteria	1. History of adverse effect on calcium channel blocker. 2. Concomitant serious cardiac diseases. 3. Hemodialysis.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Arihiro Kiyosue
Organization	The University of Tokyo Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	7-3-1 Hongo Bunkyo-ku Tokyo
TEL	03-3815-5411
Email	kiyosue-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Arihiro Kiyosue
Organization	The University of Tokyo Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	7-3-1 Hongo Bunkyo-ku Tokyo
TEL	03-3815-5411
Homepage URL
Email	kiyosue-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The University of Tokyo Hospital
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 01 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	Terminated
Date of protocol fixation	2012 Year 05 Month 17 Day
Date of IRB	2012 Year 05 Month 17 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020149