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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001950
Receipt No. 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

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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
Email

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
Email i-ohno@jikei.ac.jp

Sponsor
Institute Clinical practice of Hypertensive treatment study group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002373

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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