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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002918
Receipt No. R000003551
Scientific Title Study on efficacy and safety of aggressive antihypertensive therapy and its effect on QOL
Date of disclosure of the study information 2009/12/18
Last modified on 2009/12/18

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Basic information
Public title Study on efficacy and safety of aggressive antihypertensive therapy and its effect on QOL
Acronym S-CATS(Saga Challenge AntihyperTensive Study)
Scientific Title Study on efficacy and safety of aggressive antihypertensive therapy and its effect on QOL
Scientific Title:Acronym S-CATS(Saga Challenge AntihyperTensive Study)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 As a part of intensive medical treatment based on the guideline for treatment of hypertension, a combination drug of an ARB (losartan 50mg) and a low-dose thiazide diuretic (HCTZ 12.5mg) is to be administered in patients with uncontrolled hypertension, and its efficacy and safety are to be examined. Moreover, a questionnaire survey regarding QOL is also to be carried out in order to investigate patients' satisfaction on improvement of therapeutic effect and drug compliance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in office systolic blood pressure at 3 months after study initiation.
Key secondary outcomes - Change in office systolic blood pressure (excluding change at 3 months after study initiation), office diastolic blood pressure, home systolic blood pressure, and home diastolic blood pressure at 1, 2, 3, 6, 9 and 12 months after study initiation, and % of patients who achieved the target blood pressure
- Change and % change in EQ-5D and scores in the hypertension questionnaire at 3 and 12 months after study initiation
- Change and % change in blood glucose levels, serum potassium, serum uric acid, serum creatinine, serum cystatin-C, BNP and RLP-C at 3 and 12 months after study initiation

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 Aggressive antihypertensive therapy is to be administered by using a combination drug of an ARB and a low-dose thiazide diuretic.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with essential hypertension, who have been previously treated with an ARB alone or an ARB and a calcium channel blocker for more than 1 months, however, the target blood pressure defined by the guideline for treatment of hypertension has not been achieved
2) Patients aged 20 years and older
3) Patients who fully understand the study procedures and have given written informed consent on use of their data for the study
Key exclusion criteria 1) Patients with secondary hypertension
2) Patients with cardiac failure (NYHA grade III or IV)
3) Pregnant patients, including one trying to conceive pregnancy during the planned study period
4) Patients with severe liver dysfunction
5) Patients with renal failure (serum creatinine &#8805;2.0 mg/dL)
6) Patients with a history of hypersensitivity to ingredients of losartan or HCTZ
7) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
8) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Node
Organization Saga University Faculty of Medicine
Division name Department of Cardiovascular
Zip code
Address 5-1-1 Nabeshima, Saga-shi, Saga
TEL 0952-34-2364
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kawano
Organization Saga hypertension treatment study group
Division name secretariat
Zip code
Address Department of Cardiovascular , Saga University Faculty of Medicine , 5-1-1Nabeshima, Saga-shi, Saga
TEL 0952-34-2364
Homepage URL
Email

Sponsor
Institute Saga hypertension treatment study group
Institute
Department

Funding Source
Organization Japan Heart Foundation
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 佐賀大学医学部附属病院(佐賀県)、池田内科・皮フ科医院(佐賀県)、神崎病院(佐賀県),織田病院(佐賀県)、溝口医院(佐賀県)、田中医院(佐賀県)、うれしのふくだクリニック(佐賀県)、啓心会病院(佐賀県)、斎藤内科医院(佐賀県)、せとぐち内科(佐賀県)、小野病院(佐賀県)、諸江内科(佐賀県)、酒井内科クリニック(佐賀県)、小柳記念病院(佐賀県)、貝原医院(佐賀県)、ニコークリニック(佐賀県)、神崎クリニック(佐賀県)、山口病院(佐賀県)、蒲地医院(佐賀県)、いのうえ内科泌尿器科クリニック(佐賀県)、志田病院(佐賀県)、飯盛内科(佐賀県)、内藤医院北山診療所(佐賀県)、杏林病院(長崎県)、南医院(佐賀県)、内田クリニック(佐賀県)、ひらまつふれあいクリニック(佐賀県)、池田胃腸科外科(佐賀県)、山津医院(佐賀県)、米光クリニック(佐賀県)、山元記念病院(佐賀県)、藤川病院(佐賀県)、石田医院(佐賀県)、服巻医院(佐賀県)、江口病院(佐賀県)、枝國医院(佐賀県)、朝長医院(佐賀県)、杉原医院(佐賀県)、おおしまクリニック(佐賀県)、やましたクリニック(佐賀県)、和田内科循環器科(佐賀県)、武田内科医院(佐賀県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 18 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
2007 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2009 Year 12 Month 18 Day
Last modified on
2009 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003551

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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