UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004080 |
|---|---|
| Receipt number | 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 19:50:57 |
* 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
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
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
Sponsor or person
Institute
Diastolic Dysfunction Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004916
