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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002028
Receipt No. R000002474
Scientific Title Analysis of efficacy of Losartan and HCTZ combo on hypertension in connective tissue diseases
Date of disclosure of the study information 2009/07/31
Last modified on 2009/12/03

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Basic information
Public title Analysis of efficacy of Losartan and HCTZ combo on hypertension in connective tissue diseases
Acronym Analysis of efficacy of Losartan and HCTZ combo on hypertension in connective tissue diseases
Scientific Title Analysis of efficacy of Losartan and HCTZ combo on hypertension in connective tissue diseases
Scientific Title:Acronym Analysis of efficacy of Losartan and HCTZ combo on hypertension in connective tissue diseases
Region
Japan

Condition
Condition Collagen disease patients with hypertension
Classification by specialty
Medicine in general Cardiology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analisis of efficacy of losartan and HCTZ combo on hypertension in connective tissue disease patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes change of SBP and DBP in connective tissue disease patients
Key secondary outcomes change of SBP and DBP in general practice patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 connective tissue disease patients with hypertensin
Interventions/Control_2
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 of the connective tissue disease patient with hypertension shows the SBP140 mmHg/ DBP90 mmHg above.
Or the patients want to decrase the number of drug.
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Hagihara
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
Address 2-2, Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Hagihara
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
Address 2-2, Yamada-oka, Suita, Osaka, Japan
TEL 06-6879-3833
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Organization
Division
Category of Funding Organization
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
2009 Year 07 Month 31 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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 01 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002474

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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