Unique ID issued by UMIN | UMIN000002918 |
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Receipt number | 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 13:22:04 |
Study on efficacy and safety of aggressive antihypertensive therapy and its effect on QOL
S-CATS(Saga Challenge AntihyperTensive Study)
Study on efficacy and safety of aggressive antihypertensive therapy and its effect on QOL
S-CATS(Saga Challenge AntihyperTensive Study)
Japan |
Hypertension
Cardiology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Change in office systolic blood pressure at 3 months after study initiation.
- 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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Aggressive antihypertensive therapy is to be administered by using a combination drug of an ARB and a low-dose thiazide diuretic.
20 | years-old | <= |
Not applicable |
Male and Female
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
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 ≥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
200
1st name | |
Middle name | |
Last name | Koichi Node |
Saga University Faculty of Medicine
Department of Cardiovascular
5-1-1 Nabeshima, Saga-shi, Saga
0952-34-2364
1st name | |
Middle name | |
Last name | Hiroaki Kawano |
Saga hypertension treatment study group
secretariat
Department of Cardiovascular , Saga University Faculty of Medicine , 5-1-1Nabeshima, Saga-shi, Saga
0952-34-2364
Saga hypertension treatment study group
Japan Heart Foundation
Non profit foundation
Japan
NO
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)
2009 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2007 | Year | 05 | Month | 24 | Day |
2007 | Year | 07 | Month | 01 | Day |
2009 | Year | 06 | Month | 01 | Day |
Prospective observational study
2009 | Year | 12 | Month | 18 | Day |
2009 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003551
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