UMIN-CTR Clinical Trial

Basic information
Public title	Effect of coadministration of angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) on variability of home blood pressure in hypertensive outpatients
Acronym	Effect of ARB/CCB combination on home blood pressure variability
Scientific Title	Effect of coadministration of angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) on variability of home blood pressure in hypertensive outpatients
Scientific Title:Acronym	Effect of ARB/CCB combination on home blood pressure variability
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Medicine in general Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of ARB/CCB combination on variability of home blood pressure in outpatients with hypertension resistive to single administration of ARB or CCB
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of home blood pressure variability
Key secondary outcomes	1) Change of blood pressure at clinic and home 2) Change of pulse rate at clinic and home 3) Change of cardiac function (double product: pulse rate x systolic blood pressure) 4) Change of renal function (eGFR: estimated glomerular filtration rate) 5) Change of albuminuria 6) Incidence and degree of detrimental events

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	Change from olmesartan medoxomil 20mg/day or azelnidipine 16mg/day to coadministration of olmesartan medoxomil 20mg and azelnidipine 16mg per day for a period of 16 weeks
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Hypertensive outpatients whose blood pressures show more than 135/85mmHg for the latest period of five consecutive days despite the administration of 16mg/day azelnidipine or 20mg/day olmesartan medoxomil for a period of more than four weeks 2) Patients who are able to measure home blood pressure on their own upper arms and to write the values down in the recording notebook 3) Patients with the informed consent to this study
Key exclusion criteria	1) Patients with the past history of hypersensitivity to test drugs, other ARBs or dihydropyridine CCBs 2) Female in current or expected pregnancy 3) Patients with the past history of cerebro-cardiovascular diseases within six months 4) Patients whose blood pressures show more than 180/110mmHg 5) Patients receiving the dialysis therapy or with severe renal dysfunction (eGFR<30ml/min/1.73m2) 6) Patients with severe hepatic dysfunction (showing more than 100 IU/L of AST or ALT) 7) Patients receiving treatment for a malignant neoplasm 8) Patients taking a contraindication drug for coadministration of test drugs 9) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Kashihara
Organization	Kawasaki Medical School
Division name	Department of Nephrology and Hypertension
Zip code	7010192
Address	577 Matsushima, Kurashiki, Okayama 701-0192
TEL	086-462-1111
Email	kashinao@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Hajime Middle name Last name Nagasu
Organization	Kawasaki Medical School
Division name	Department of Nephrology and Hypertension
Zip code	7010192
Address	577 Matsushima, Kurashiki, Okayama 701-0192
TEL	086-462-1111
Homepage URL
Email	hajimenagasu@kms-ndh.com

Sponsor
Institute	Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department

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	Kawasaki Medical School
Address	577 Matsushima, Kurashiki, Okayama 701-0192
Tel	086-462-1111
Email	kmsrec@med.kawasaki-m.ac.jp

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	2013 Year 04 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	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2014 Year 10 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	2013 Year 03 Month 12 Day
Last modified on	2020 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011436