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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004080
Receipt No. R000004916
Scientific Title Effect of Losartan/HCTZ on diastolic function in patients with hypertension 2 Comparison with ARB/CCB combined therapy
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/20

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Basic information
Public title Effect of Losartan/HCTZ on diastolic function in patients with hypertension 2
Comparison with ARB/CCB combined therapy
Acronym Effect of ARB/Diuretics on left ventricular diastolic dysfunction
EDEN 2
Scientific Title Effect of Losartan/HCTZ on diastolic function in patients with hypertension 2
Comparison with ARB/CCB combined therapy
Scientific Title:Acronym Effect of ARB/Diuretics on left ventricular diastolic dysfunction
EDEN 2
Region
Japan

Condition
Condition Hypertension patients with left ventricular diastolic dysfunction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of ARB/HCTZ and ARB/CCB on left ventricular diastolic dysfunction in hypertension patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in e' and e'/E
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 ARB/HCTZ
Interventions/Control_2 ARB/CCB
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 Hypertension patients are those who have been treated with anti hypertensive therapy including ARB usual dose and whose blood pressure has not been sufficinetly controlled
Left ventricular diastolic dysfunction patients
LVEF >=50%
e'<8cm/s and or E/e' >=15
Outpatiens
Obtaining written informed consent
Key exclusion criteria Insufficiently controlled hypertension DBP more than 110mmHg
Secondary hypertension
Diabetes mellitus patient under insulin treatment
Onset of myocardial infarction or stroke within 6 months before recruiting
Concurrent hepatic dysfunction GPT more than 3 times the upper limit of normal values
Renal dysfunction sCr more than 2.0 mg/dL
Gout or hyperuricemia uric acid more than 8.0 mg/dL
Heart failure with NYHA 3 or more
AF undergo echocardiography
Valvular disease
Malignant tumor and/or poor prognosis severe disease
Women who are pregnant, enable to be pregnant, or are breastfeeding
Concurrent treatment with diuretics and/or CCB
Hypersensitivity or allergy to losartan, HCTZ and amlodipine
Hypersensitivity or allergy to thiazide and other analogs
Patients who are determined by the investigators to be unsuitable
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization Okayama University Medical School
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1 Shikada-cho Kita-ku Okayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Diastolic Dysfunction Study Group
Division name Secretariat Office
Zip code
Address 2-5-1 Shikada-cho Kita-ku Okayama
TEL
Homepage URL
Email

Sponsor
Institute Diastolic Dysfunction Study Group
Institute
Department

Funding Source
Organization Osaka Prevention Institute for Cancer and Cardiovascular Diseases 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

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Enrolling by invitation
Date of protocol fixation
2010 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 20 Day
Last modified on
2010 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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