UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005726
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of Cardiovascular Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.