UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001950 |
|---|---|
| Receipt number | R000002373 |
| Scientific Title | The JOINT Study :Evaluation of effect and safty of Losartan/Hydrochlorothazide fixed dose combination for hypertensive patients |
| Date of disclosure of the study information | 2009/05/08 |
| Last modified on | 2011/11/14 17:50:42 |
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Basic information
Public title
The JOINT Study
:Evaluation of effect and safty of Losartan/Hydrochlorothazide fixed dose combination for hypertensive patients
Acronym
The JOINT Study
The Jikei Optimal Anti-hypertension Treatment Study
Scientific Title
The JOINT Study
:Evaluation of effect and safty of Losartan/Hydrochlorothazide fixed dose combination for hypertensive patients
Scientific Title:Acronym
The JOINT Study
The Jikei Optimal Anti-hypertension Treatment Study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of lowering blood pressure and safty and medication cost of Losartan/Hydrochlorothizide fixed dose combination in uncontrolled hypertensive patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in systolic and diastolic blood pressure after 3 months of treatment
Key secondary outcomes
Change in home blood pressure, serum uric acid, microalbuminuria, BNP after 3 months of treatment
Change in serum uric acid, microalbuminuria, BNP, medication cost after 6 months of treatment
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
Losartan/Hydrochlorothizide
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Hypertensive patients, whose blood pressure has not been reached the target levels SBP>130mmHg or DBP>80mmHg.
(2)Patients who have been treated by 1 to 3 antihypertensive drugs.
(3)Outpatients
(4)Men and women aged 20 to 75 years
Key exclusion criteria
(1)Patiens with renal failure(serum creatinine >2.5 mg/dL
(2)Patients with liver dysfunction [GPT(ALT) over three times the normal value]
(3)Pregnant or possible pregnant women
(4)Breast-feeding women
(5)Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Hosoya |
Organization
Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
3-25-8 Nishi-Shinbashi Minato-ku Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwao Ohno |
Organization
Jikei University School of Medicine
Division name
Division of Kidney and Hypertension
Zip code
Address
3-25-8 Nishi-Shinbashi Minato-ku Tokyo
TEL
03-3433-1111
Homepage URL
i-ohno@jikei.ac.jp
Sponsor or person
Institute
Clinical practice of Hypertensive treatment study group
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation,Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 | 05 | Month | 08 | 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
| 2008 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2009 | Year | 05 | Month | 08 | Day |
Last modified on
| 2011 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002373
