UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002028 |
|---|---|
| Receipt number | 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 11:14:05 |
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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
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
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002474
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
