UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002851 |
|---|---|
| Receipt number | 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 | 2021/05/23 16:12:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Kazuyuki |
| Middle name | |
| Last name | Shimada |
Organization
Shin-Oyama City Hospital
Division name
Cardiology
Zip code
323-0827
Address
2251-1, oaza hitotonoya, Oyama City, Tochigi Pf.
TEL
0285-36-0203
kazuyuki@hospital.oyama.tochigi.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Usami |
Organization
RESPECT-Study Group
Division name
Secretariat & Data Center
Zip code
192-0902
Address
584-1-908 Kitano-cho Hachiouji-City Tokyo
TEL
042-649-1113
Homepage URL
http://www.respect-study.com
respect-study@respect-study.jp
Sponsor or person
Institute
Nonprofit Organization RESPECT Study Group
Institute
Department
Personal name
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
Nonprofit Organaization RESPECT Study group
Address
584-1-908 Kitano-cho Hachioji-City Tokyo Japan 192-0906
Tel
042-649-1113
respect-study@respect-study.jp
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
| 2010 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 20 | 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
| 2021 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.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 |
