UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation
Title of the study (Brief title)	Angiotensin receptor blocker/Calcium antagonist combination therapy on diurnal blood pressure variation
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To examine the effects of AIMIX(R) combination tablet (Amlodipine 10mg/Irbesartan 100mg) therapy on blood pressure reduction and organ damage protection and to document side effects. 2) To document the proportion of extreme-dipper, dipper, non-dipper and riser in the patients who are poorly controlled hypertension (clinic systolic BP more than or equal to 140/90 mm Hg despite the combination therapy with Calcium antagonist [Amlodipine 5mg] and angiotensin II receptor antagonist [any one of the following drugs: losartan 50mg, valsartan 80mg, candesartan 8mg, telmisartan 40mg, olmesartan 20mg, azilsartan 20mg]). 3) To document the proportion of extreme-dipper, dipper, non-dipper and riser in patients treated with AIMIX(R) combination tablet.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Target blood pressure reduction rate (clinic blood pressure less than 140/90 mm Hg ). - To document the proportion of extreme-dipper, dipper, non-dipper and riser (diurnal blood pressure variation).
Key secondary outcomes	- Target blood pressure achievement rate and blood pressure lowering level at the final assessment. - Change in serum creatinine level (e-GFR) and microalbumin level. *eGFR(mL/min/1.73m2) = 194 X Cr -1.094 X age -0.287 X Cr -1.154 (X 0.739 for women) - Change in highly sensitive cardiac troponin T (hs-cTnT), NT-proBNP.

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	AIMIX(R) combination tablet
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	Patients who meet all of the following criteria: Patients aged 20 years old and over. Patients who have clinic systolic BP more than or equal to 140/90 mm Hg despite the combination therapy with Calcium antagonist (Amlodipine 5mg) and angiotensin II receptor antagonist (any one of the following drugs: losartan 50mg, valsartan 80mg, candesartan 8mg, telmisartan 40mg, olmesartan 20mg, azilsartan 20mg).
Key exclusion criteria	Patients who meet one of the following criteria are excluded: 1) Secondary hypertension 2) Congestive heart failure; onset of acute myocardial infarction in the past 6 month; onset of cerebrovascular disturbance in the past 6 month; current atrial fibrillation or atrioventricular block or severe arrhythmia. 3) hepatic insufficiency (AST or ALT >X2 the upper limit of the normal range) , renal insufficiency (serum Crl.>1.5mg/dL) 4) Diabetic patients being treated with aliskiren. 5) Allergy or drug hypersensitivity. 6) Lack of the informed consent for any reason (e.g. dementia). 7) Women suspected of being pregnant. 8) Patients being ineligible by the attending physicians.
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine,
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL	0285-44-2130
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	Satoshi Hoshide
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine,
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL	0285-44-2130
Homepage URL
Email	hoshide@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine
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)

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	2014 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 09 Day
Anticipated trial start date	2014 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 03 Day
Last modified on	2017 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015213