Status:
UNKNOWN
Recurrent Stroke Prevention Clinical Outcome Study
Lead Sponsor:
Biomedis International Ltd.
Conditions:
Hypertension
Stroke
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
1. Objectives and Hypothesis 1. Objectives: This study evaluates whether strict BP management is useful for the prevention of recurrent stroke. Hypertensive patients with history of ...
Detailed Description
Rationale for Study Duration Predicting that strict BP control reduces the relative risk of recurrent stroke by 30% during the planned observation period of 3 years, the number of participants necessa...
Eligibility Criteria
Inclusion
- Participants include those with essential hypertension and history of stroke who satisfy the following criteria:
- Outpatient
- Onset of stroke(cerebral infarction/cerebral hemorrhage) occurred between 30 days and 3 years prior to the date of consent.
- Drug adherence is ≧80% during the screening period.
- Mean of 2 baseline BP measurements(measured at outpatient clinic) within 30 days prior to the date of consent is either 180 \>SBP ≧130 mmHg or 110 \>DBP ≧80 mmHg (untreated -3 anti hypertensive agents patients).
- Cerebral infarction with severity 3 or less in the modified Rankin scale.
Exclusion
- Patient who meets any one of the following criteria is excluded from the study.
- Women who are pregnant, are possible pregnant, or are breastfeeding
- Possible secondary hypertension
- Severe hypertension (grade III or greater) with baseline SBP ≧180 mmHg or DBP ≧110 mmHg)
- Myocardial infarction or undergoing angioplasty occurred within 3 months prior to the screening.
- Current or previous heart failure with NYHA classification class III or more, or EF less than 35%
- Severe bilateral carotid stenosis or major cerebral artery occlusion
- Severe paralysis due to stroke (modified Rankin scale ≧ 4 )
- Current renal dysfunction (serum Cr ≧ 2.0 mg/dL right before the date of consent)
- Current hepatic dysfunction with AST or ALT value ≧ 100 IU/mL right before the date of consent
- Refractory hypertension treated with four or more antihypertensive drugs
- Hypersensitivity or allergy to losartan and other angiotensin II receptor blockers, hydrochlorothiazide, amlodipine or sulfonamide derivative
- Major surgery planned during the study period
- Participants of other clinical studies within the last 30 days
- Current malignancy (previous malignancy within 5 years after the end of treatment) excluding squamous-cell skin cancer
- Previous and current subarachnoid hemorrhage
- Definitive dementia 12) (based on a clinical diagnosis)
- Patients who have difficulty in signing consent or who do not agree to the provided consent
- Patients who are judged to be unsuitable for participating the study by the primary investigator or sub-investigator.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01198496
Start Date
October 1 2010
End Date
December 1 2019
Last Update
July 31 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jichi Medical Univercity
Shimotsuke, Tochigi, Japan, 329-0498