UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002918
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

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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 or person

Institute

Saga hypertension treatment study group

Institute

Department

Personal name



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

Value
https://center6.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