UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005726 |
|---|---|
| Receipt number | R000006772 |
| Scientific Title | Comparison of add-on treatment with Aliskiren versus Diuretics to angiotensin II receptor blocker based Therapy |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2013/12/06 09:58:53 |
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Basic information
Public title
Comparison of add-on treatment with Aliskiren versus Diuretics to angiotensin II receptor blocker based Therapy
Acronym
Aliskiren Evaluation on Augmentation Index (ALEA) study
Scientific Title
Comparison of add-on treatment with Aliskiren versus Diuretics to angiotensin II receptor blocker based Therapy
Scientific Title:Acronym
Aliskiren Evaluation on Augmentation Index (ALEA) study
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a Direct renin inhibitor, aliskiren as an additional medicine to ARB, and an additional Diuretic, fluitran, on central arterial pressure AI as the main index in essential hypertension patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in AI, Center blood pressure, SBP2 after 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Direct renin inhibitor
Interventions/Control_2
Diuretic
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, From age 30 years old to 85 years old and sex is not asked
2, The patients with SBP 140mmHg or more or DBP 90mmHg or more though it is treatment by the valsartan 80mg ,angiotensin II receptor blocker (ARB).
Key exclusion criteria
1, Secondary hypertension
2, Severe hypertension(SBP 200mmHg or more or DBP 115mmHg or more)
3, Congestive heart failure
4, Severe valvular disease
5, Myocardial infarction or acute period of cerebrovascular disease(within 6 months)
6, Atrial fibrillation(paroxysmal,stained,chronic)
7, Malignant ventricular arrhythmia
8, Renal insufficiency(Serum creatinine 2mg/dL or more)
9, Severe Liver Dysfunction
10, Chronic inflammatory disease
11, The patient with a malignant tumor
12, Patients who are determined by the investigators to be unsuitable
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
The Okayama Medical Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
岡山大学病院（岡山県）、香川県立中央病院（香川県）、住友別子病院（愛媛県）、津山中央病院（岡山県）、屋島総合病院（香川県）、心臓病センター榊原病院（岡山県）、岡山ハートクリニック（岡山県）、岩国医療センター（山口県）、笠岡第一病院（岡山県）、済生会今治病院（愛媛県）、福山医療センター（広島県）、岡山市民病院（岡山県）、由良病院（岡山県）、長谷川記念病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
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
| 2011 | Year | 06 | Month | 06 | Day |
Last modified on
| 2013 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006772
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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