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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000017785 |
Receipt No. | R000020601 |
Scientific Title | A study of irbesartan/amlodipine on hypertensive patients |
Date of disclosure of the study information | 2015/06/03 |
Last modified on | 2015/09/07 |
Basic information | ||
Public title | A study of irbesartan/amlodipine on hypertensive patients | |
Acronym | AIMIX study | |
Scientific Title | A study of irbesartan/amlodipine on hypertensive patients | |
Scientific Title:Acronym | AIMIX study | |
Region |
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Condition | ||
Condition | Hypertension | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To study the antihypertensive and renal protective effects of irbesartan/amlodipine. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Blood pressure change |
Key secondary outcomes |
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 |
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Interventions/Control_1 | Irbesartan/Amloipine | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Hypertensive patients | |||
Key exclusion criteria | 1) Allergy to Irbesartan/Amloipine
2) Renal aretery stenosis of one or both sides 3) Severe liver dysfunction 4) Alcoholic or drug abuse 5) Pregnancy or nursing 6) Myocardial and cerebral infarction in three months 7) Blood tests are as follows. a) AST or ALT more than 2.5 folds or equal to standard values b) Total bilirubin more than or equal to 3.0 mg/dL c) Serum creatinine more than or equal to 2.5 mg/dL d) Serum potassium more than or equal to 5.0 mEq/L 8) Other inappropiate patients |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kumamoto University | ||||||
Division name | Department of Cardiology | ||||||
Zip code | |||||||
Address | 1-1-1 Honjo, Chuo-ku, Kumamoto-city | ||||||
TEL | 096-373-5175 | ||||||
ogawah@kumamoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kumamoto University | ||||||
Division name | Department of Cardiology | ||||||
Zip code | |||||||
Address | 1-1-1 Honjo, Chuo-ku, Kumamoto-city | ||||||
TEL | 096-373-5393 | ||||||
Homepage URL | |||||||
o-yasuda@kumamoto-u.ac.jp |
Sponsor | |
Institute | Kumamoto University |
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) |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020601 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |