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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003846
Receipt No. R000004631
Scientific Title Effect of ARB and diuretics combination therapy on home blood pressure by using telemedicine system
Date of disclosure of the study information 2010/06/30
Last modified on 2010/07/01

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Basic information
Public title Effect of ARB and diuretics combination therapy on home blood pressure by using telemedicine system
Acronym PRETTY HOME TRIAL
Scientific Title Effect of ARB and diuretics combination therapy on home blood pressure by using telemedicine system
Scientific Title:Acronym PRETTY HOME TRIAL
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of ARB and diuretics combination therapy and high-dose ARB on home blood pressure by using telemedicine system. The hypertensive patients (Over 140/90 mmHg) treated with 50 mg dose of Losartan were recruited in this study. These patients were devited into two groups as follows; one group is treated with 50mg dose of Losartan plus 12.5mg dose of Hydrochlorthiaside, and the other group is treated with 100mg dose of Losrtan. To compare the efficacy and safety of combinatiion therapy of ARB plus low dose diuretics vs. high-dose ARB, home blood pressure of these patients were monitored by telemedicine system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Moning blood pressure
Key secondary outcomes Evening blood pressure
Insulin sensitivity
Metabolic factora

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preminent treated group
(Losartan 50mg+Hydrochrolthiazide 12.5mg)
Interventions/Control_2 NLosartan 100mg
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 Blood pressure over 140/90 mmHg treated with 50mg dose of Losartann
Key exclusion criteria Secondary Hypertension
Pregnancy
Heart Failure with NYHA stage III
ESRD patients Cr over 2.0
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetomo Nakamoto
Organization Saitama Medical University
Division name General Internal Medicine
Zip code
Address 38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL 049-276-1667
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidetomo Nakamoto
Organization Saitama Medical University
Division name General Internal Medicine
Zip code
Address 38Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Homepage URL
Email nakamo_h@saitama-med.ac.jp

Sponsor
Institute Department of General Internal Medicine, Saitama Medical School
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Saitama 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 埼玉医科大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 30 Day
Last modified on
2010 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004631

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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