Essential hypertension with history of Stroke
Conditions
Interventions
Blood pressure manegement usig antihypertensive agents as range SBP LT 140 mmHg or DBP LT 90 mmHg
Blood pressure manegemrnt using antihypertensive agents as range SBP LT 120 mmHg or DBP 80 mmHg
Sponsors
Nonprofit Organization RESPECT Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of cerebral infarction and cerebral hemorrhage 244 cesed will be collected based on event driven method | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroko Usami
RESPECT-Study Group Secretariat & Data Center
Outcome results
None listed