UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013343 |
|---|---|
| Receipt number | 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 17:26:38 |
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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
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
nsato@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015517
