UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016251 |
|---|---|
| Receipt number | R000018862 |
| Scientific Title | Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine |
| Date of disclosure of the study information | 2015/01/17 |
| Last modified on | 2017/01/19 21:24:27 |
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Basic information
Public title
Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine
Acronym
4A study
Scientific Title
Efficacy and safety of a single-pill fix dose combination of azilsartan and amlodipine
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
saku-k@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Miura |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
Homepage URL
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
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
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018862
