UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013343
Receipt No. R000015517
Scientific Title Assessment of suitable Antihypertensive therapies: Combination with high dose amlodipine/Irbesartan vs. triple combination with amlodipine/Irbesartan/Indapamide
Date of disclosure of the study information 2014/03/06
Last modified on 2020/09/15 (Ver. 6)

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Basic information
Public title Assessment of suitable Antihypertensive therapies:
Combination with high dose amlodipine/Irbesartan vs.
triple combination with amlodipine/Irbesartan/Indapamide

Acronym ASAHI-AI study
Scientific Title Assessment of suitable Antihypertensive therapies:
Combination with high dose amlodipine/Irbesartan vs.
triple combination with amlodipine/Irbesartan/Indapamide

Scientific Title:Acronym ASAHI-AI study
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy of an increased regimen of Ca channel blockers and adding diuretics for treating the blood pressure in patients with essential hypertension who failed to achieve the target blood pressure by a combination therapy with ARBs and Ca channel blockers
We examine non-inferiority of Irbesartan 100mg/Amlodipine 10mg to triple combination with Amlodipine 10mg /Irbesartan 100mg /Indapamide 1mg for reduction of blood pressure.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Systolic/Diastolic blood pressure change after a 12 week treatment
Key secondary outcomes Blood pressure change (home blood pressure monitoring in the morning and at night)
Change in the ambulatory blood pressure (ABPM)
The rate of achieving the target blood pressure
Change in the laboratory data
Systolic/Diastolic blood pressure change after a 24 week treatment
The rate of continued treatment and the compliance of the treatment at 24 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Increased Ca channel blocker regimen group
Up to 12 weeks: Irbesarten100mg/amlodipine 10mg
From 12 weeks to 24 weeks: antihypertensive drugs other than ARBs, Ca channel blockers, and diuretics are added if needed
Interventions/Control_2 Adding Diuretics regimen group
Up to 12 weeks: 1mg Indapamide
From 12 weeks to 24 weeks: antihypertensive drugs other than ARBs, Ca channel blockers, and diuretics are added if needed
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with essential hypertension, who have been previously treated with ARBs and Ca channel blockers (Irbesartan 100mg/Amlodipine 5mg or usual dosage of ARBs/Amlodipine 5mg) and whose blood pressure has not been adequately controlled with the treatment ( SBP>=140mmHg and /or DBP>=90mmHg).
2) Age more than 20 and less than 85 years
3) Outpatients
4) Patients understand the study procedures and agree to participate in the study by giving written informed consent prior to the start of the study.

Key exclusion criteria 1) Patients with secondary hypertension
2) Patients with a history of severe renal disease: serum creatinine>2.0 mg/dl
3) Patients with critical liver damage (AST or ALT>100 IU/l)
4) Patients with a history of adverse effects to ARBs
5) Bilateral renal artery stenosis
6) Patients with hyperkalemia >=5.5 mEq/L
7) Patients with pregnancy or breast-feeding
8) Patients with a poor prognosis such as a malignant tumor
9) Patients who are considered not to be eligible for the study by the investigator due to medical reasons
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name Hasebe
Organization Asahikawa Medical University
Division name Cardiovascular Respiratory and Neurology Division, Department of Internal Medicine
Zip code 078-8510
Address Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2442
Email haselove@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Sato
Organization Asahikawa Medical University
Division name Cardiovascular Respiratory and Neurology Division, Department of Internal Medicine
Zip code 078-8510
Address Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2442
Homepage URL
Email nsato@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Self funding
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 Asahikawa Medical University Research Ethics Committee
Address Midorigaoka Higashi 2-1-1-1, Asahikawa City, Hokkaido
Tel 0166-68-2297
Email rs-kk.g@asahikawa-med.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
2014 Year 03 Month 06 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/10.1111/jch.13977
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/10.1111/jch.13977
Number of participants that the trial has enrolled 94
Results 
High-dose CCBs combined with ARBs and a triple combination with diuretics combined with standard-dose CCB/ARBs produced
a similar efficacy in reducing the BP. Both
combination therapies can be used safely and effectively in hypertensive patients uncontrolled by standard doses of ARBs and CCBs.
Results date posted
2020 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Japanese hypertensive patients, who had not attained the BP goal with a combination therapy with usual dosages of ARBs plus CCB
Participant flow 
A total of 97 patients were considered to be eligible for the study;
however, three patients who met the exclusion criteria were excluded.
Adverse events 
No adverse events
Outcome measures 
The primary end point is a change in the SBP/DBP after a 12-week treatment.  The secondary end points are BP changes after the 24-week treatment period, and laboratory values.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 02 Month 25 Day
Date of IRB
2014 Year 02 Month 24 Day
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 05 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/icdr_e/ctr_view.cgi?recptno=R000015517