UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine
Title of the study (Brief title)	4A study
Region	Japan

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

Objectives
Narrative objectives1	Combinations of angiotensin II type 1 receptor blockers (ARBs) and calcium channel blockers (CCBs) are recommended by various guidelines for the treatment of high blood pressure. Many kinds of single-pill fixed-dose combinations of ARBs and CCBs are available for clinical use in Japan. It is still controversial what types of single-pill fixed-dose combinations of ARBs and CCBs are useful. Therefore, we compared the efficacies and safety of single-pill fixed-dose combinations of ARBs and CCBs (azilsartan and amlodipine vs. valsartan and amlodipine or irbesartan and amlodipine).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Depressor effects at office blood pressure
Key secondary outcomes	1.The percentage of patients who reach the target office blood pressure. 2.Changes in biochemical parameters in blood and urine.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients receive a single-pill fixed-dose combination of a single-pill fixed-dose combination of azilsartan/amlodipine and treated for 16 weeks. If the patient dose not reach the target office blood pressure at 8 weeks according to Japanese Society of Hypertension Guideline 2014, they received double doses of amlodipine.
Interventions/Control_2	The patients receive a single-pill fixed-dose combination of valsartan/amlodipine or irbesartan/amlodipine and treated for 16 weeks. If the patient dose not reach the target office blood pressure at 8 weeks according to Japanese Society of Hypertension Guideline 2014, they received double doses of 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with hypertension who receive a single-pill fixed-dose combination of valsartan/amlodipine or irbesartan/amlodipine 2.Age is 20 years old or more. 3.Patients who give their informed consent to participate for the present study.
Key exclusion criteria	1.Severe liver dysfunction. 2.Severe renal dysfunction. 3.Pregnancy or lactation in women. 4.Patients with a history of allergy to any component of the study medications. 5.Patients corresponding to the contraindication of study medications. 6.Ineligible patients according to the judgment by physician.
Target sample size	40

Research contact person
Name of lead principal investigator	Keijiro Saku
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Email	saku-k@fukuoka-u.ac.jp

Public contact
Name of contact person	Shin-ichiro Miura
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	81-92-801-1011
Homepage URL
Email	miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute	Department of Cardiology, Fukuoka University School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology, Fukuoka University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	福岡大学病院（福岡県）、井上病院（福岡県）、藤沢内科（福岡県）、松永病院（福岡県）、城谷病院（福岡県）、出水総合医療センター（鹿児島県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 30 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2016 Year 03 Month 30 Day
Date of closure to data entry	2016 Year 07 Month 30 Day
Date trial data considered complete	2016 Year 07 Month 30 Day
Date analysis concluded	2016 Year 08 Month 29 Day

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

Management information
Registered date	2015 Year 01 Month 17 Day
Last modified on	2017 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018862