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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002487
Receipt No. R000003047
Scientific Title The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Date of disclosure of the study information 2009/11/01
Last modified on 2018/03/21

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Basic information
Public title The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Acronym The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Scientific Title The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Scientific Title:Acronym The effect of aggressive antihypertensive therapy in hypertensive patients with left ventricular diastolic dysfunction
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of a combination drug of an angiotenshin II receptor blockers (ARB) and a low-dose diuretic vs combination therapy with an ARB and an angiotensin converting enzyme (ACE) inhibitor in hypertensive patients with left ventricular diastolic dysfunction. In addition to the effect on left ventricular diastolic dysfunction, the study aims to evaluate the efficacy on myocardial hypertrophy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 48 weeks of treatment
Key secondary outcomes - Change and % change in left ventricular hypertrophy and left ventricular diastolic function after 24 weeks of treatment
- Change and % change in blood pressure after 4, 24 and 48 weeks of treatment
- Change and % change in BNP, cathecholamine 3 fractionation, hs-CRP, plasma renin activity and aldosterone levels after 24 and 48 weeks of treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Losartan/HCTZ group
Interventions/Control_2 Losartan (50mg) and Enalapril (5mg) combination group
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
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria:
1) Outpatients (men and women) aged 20 to 80 years at the time of the first visit
2) Patients with hypertension, who have been previously treated with monotherapy of a standard-dose of ARB for more than 1 month, however, whose blood pressure has not been adequately controlled (systolic blood pressure>=140mmHg and/or diastolic blood pressure>=90mmHg)
3) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study
Key exclusion criteria Exclusion criteria:
1) Patients with secondary hypertension
2) Patients with uncontrolled hypertension (DBP>=120mmHg)
3) Patients with uncontrolled diabetes (HbA1c>=8.0%)
4) Patients with cardiac insufficiency (over NYHA grade III)
5) Patients with renal failure (serum creatinine>=2.0mg/dl)
6) Patients with liver dysfunction (GOT or GPT>=100IU/L)
7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (UA>=8.0mg/dl)
8) Patients with hyperkalemia (K>=5.5mEq/L)
9) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
10) Patients with a history of hypersensitivity to ingredients of the study drugs
11) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoji Neishi
Organization Kawasaki Medical School
Division name Division of Cardiology
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email neishi@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Neishi
Organization Kawasaki Medical School
Division name Division of Cardiology
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email neishi@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 川崎医科大学 (岡山県)

Kawasaki Medical School (Okayama)

Other administrative information
Date of disclosure of the study information
2009 Year 11 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
2009 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 13 Day
Last modified on
2018 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003047

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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