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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002851
Receipt No. R000003481
Scientific Title A large-scale clinical study to investigate the secondary preventive effect of strict antihypertensive therapy in patients with a previous history of strok
Date of disclosure of the study information 2010/01/31
Last modified on 2018/06/12

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Basic information
Public title A large-scale clinical study to investigate the secondary preventive effect of strict antihypertensive therapy in patients with a previous history of strok
Acronym Recurrent Stroke Prevention Clinical Outcome Study(RESPECT-Study)
Scientific Title A large-scale clinical study to investigate the secondary preventive effect of strict antihypertensive therapy in patients with a previous history of strok
Scientific Title:Acronym Recurrent Stroke Prevention Clinical Outcome Study(RESPECT-Study)
Region
Japan

Condition
Condition Essential hypertension with history of Stroke
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Neurology Geriatrics Vascular surgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of stringent blood pressure lowering for prevention of recurrence of stroke
Basic objectives2 Others
Basic objectives -Others Correlation between Blood pressure vs recurrence of stroke
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Recurrence of cerebral infarction and cerebral hemorrhage 244 cesed will be collected based on event driven method
Key secondary outcomes Duration from date of IC taken up to end of observation period
1 cerebral infarction with TOAST's definition
2 cerebral hemorrhage
3 subaracunoid hemorrhage
4 tansit ischemic attack
5 myocardial infarction
6 composit cardiovascular event cerdiovascular death nonfatal stroke nofatal myocardial infarction
7 total death
8 total death nonfatal stroke nonfatal myocardial infarction


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Blood pressure manegement usig antihypertensive agents as range SBP LT 140 mmHg or DBP LT 90 mmHg
Interventions/Control_2 Blood pressure manegemrnt using antihypertensive agents as range SBP LT 120 mmHg or DBP 80 mmHg
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Subjects for this study are patients with essential hypertension who satisfy the following criteria
1 Receiving outpatient treatment
2 Onset of cerebral infarction or cerebral hemorrhage at least 30 days prior to IC taken
3 Treatment compliance of more than 80% during the screening period
4 Mean of 2 times outpatient BP measurements at baseline being
SBP LT 180mmhg-MT 140 mmHg and DBP LT 110mmHg-MT 80mmHg
5 Severity of cerebral infarction on the modified Rankin score LT 3
Key exclusion criteria 1 Women who are pregnant, wish to become pregnant, or are breastfeeding
2 Secondary hypertension
3 Concurrent of severe hypertension baseline SBP MT 180mmHg or baseline DBP MT 110mmHg
4 Onset of myocardial infarction or undergoing angioplasty within 3 months before recruiting
5 Concurrent or history of heart failure with NYHA functional classification class III or more, or EF <35%
6 Severe bilateral carotid stenosis or major cerebral artery occlusion
7 Severe paralysis due to stroke (Modified Rankin Scale MT 4)
8 Significant renal dysfunction identified in laboratory test within 1 year prior to IC taken Serum creatine MT 2.0mg/dL
9 Significant liver dysfunction identified in laboratory test within 1 year prior to IC taken AST(GOT) MT 100IU/mL or ALT(GPT) MT 100IU/mL
10 Patient with oral administration of 4 or more anti-hypertensive agents prior to IC taken
11 Hypersensitivity or allergy to losartan and other AII antagonists, HCTZ or sulfonamide derivative
12 Patients who will be scheduled receiving any surgery within a study period
13 Being treated with other investigational products within 30 days prior to IC taken
14 Patients who are required any treatmentfor or history of malignant neoplasm
15 Concurrent or history of subarrachnoid hemmorhage
16 Patient with a definit dementia
17 Patients from whom it is difficult to obtain informed consents
18 Patients who are determined by the primary investigator or co-investigator to be unsuitable
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Shimada
Organization Shin-Oyama City Hospital
Division name Cardiology
Zip code
Address 2251-1, oaza hitotonoya, Oyama City, Tochigi Pf.
TEL 0285-36-0203
Email kazuyuki@hospital.oyama.tochigi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Usammi
Organization RESPECT-Study Group
Division name Secretariat & Data Center
Zip code
Address 584-1-908 Kitano-cho Hachiouji-City Tokyo
TEL 042-649-1113
Homepage URL http://www.respect-study.com
Email respect-study@respect-study.jp

Sponsor
Institute Nonprofit Oganization RESPECT Study Group
Institute
Department

Funding Source
Organization Nonprofit Organaization RESPECT Study group
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 Clinical Trial.gov Identifier:NCT01198496
Org. issuing International ID_1 The SERVICE of the US National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 自治医科大学(栃木県)、札幌医科大学(北海道)、北海道大学(北海道)、京都府立医科大学(京都府)、京都大学(京都府)、大阪大学(大阪府)、国立循環器病研究センター(大阪府)、東京女子医科大学(東京都)、埼玉医科大学国際医療センター(埼玉県)計193施設

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 31 Day

Related information
URL releasing protocol http://www.respect-study.com
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 No longer recruiting
Date of protocol fixation
2009 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 06 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003481

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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