Back to resultsThe Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
losartan
amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Patient With Tia Or Ischemic Stroke (Event Has Occurred More Thaan 4 Weeks But Less Than 24 Weeks, And Modified Rankin'S Scale, Mrs<=3) With Mild To Moderate Hypertension
- Patient Has No Other Active Medical Problem, Which Might Of Itself Or By This Treatment Significantly Affect The Patient's Blood Pressure
- The Blood Level Of Hscrp>0.2 Ng/Dl By Two Measurements Performed Respectively One-Week Apart
Exclusion Criteria:
- Patients With Cardiac Arrhythmia
- Diabetes Mellitus
- Patient With Other Active Inflammatory Diseases Such As Rheumatoid Disease, Fever And Systemic Infection Which Will Confound The Level Of Serum CRP
- Patients With Known Intolerance, Contraindication Or Hypersensitivity To Losartan, Amlodipine and Hydrochlorothiazide
- Patient With Myocardial Infarction Within The Recent Three Months
- Anatomy Abnormality Which Results In Poor Bilateral Temporal Acoustic Windows Which Prevent TCD Procedure
- Patient Who Requires Continuous Medication With Alpha Blocking Agents
- Concurrent Usage Of Acei
- Poor Mental Function Or Any Other Reason To Expect Difficulty In Meeting The Requirements Of The Study
- Concurrent Treatment With Other Lipid-Lowering Drug
- Childbearing Potential Women Not Undergoing Adequate Contraceptive Control
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Losartan 50mg qd for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
Amlodipine 5 mg q.d for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
Outcomes
Primary Outcome Measures
MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30.
Secondary Outcome Measures
Full Information
NCT ID
NCT00754429
First Posted
September 16, 2008
Last Updated
October 22, 2013
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00754429
Brief Title
The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)
Official Title
The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
5. Study Description
Brief Summary
To compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Losartan 50mg qd for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Amlodipine 5 mg q.d for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
Intervention Type
Drug
Intervention Name(s)
losartan
Other Intervention Name(s)
losartan potassium, COZAAR®, MK0954
Intervention Description
losartan 50mg qd for 30 weeks.
Intervention Type
Drug
Intervention Name(s)
amlodipine
Other Intervention Name(s)
Norvasc
Intervention Description
amlodipine 5 mg q.d for 30 weeks.
Primary Outcome Measure Information:
Title
MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30.
Time Frame
At week 0, week 6, week 18 and week 30.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient With Tia Or Ischemic Stroke (Event Has Occurred More Thaan 4 Weeks But Less Than 24 Weeks, And Modified Rankin'S Scale, Mrs<=3) With Mild To Moderate Hypertension
Patient Has No Other Active Medical Problem, Which Might Of Itself Or By This Treatment Significantly Affect The Patient's Blood Pressure
The Blood Level Of Hscrp>0.2 Ng/Dl By Two Measurements Performed Respectively One-Week Apart
Exclusion Criteria:
Patients With Cardiac Arrhythmia
Diabetes Mellitus
Patient With Other Active Inflammatory Diseases Such As Rheumatoid Disease, Fever And Systemic Infection Which Will Confound The Level Of Serum CRP
Patients With Known Intolerance, Contraindication Or Hypersensitivity To Losartan, Amlodipine and Hydrochlorothiazide
Patient With Myocardial Infarction Within The Recent Three Months
Anatomy Abnormality Which Results In Poor Bilateral Temporal Acoustic Windows Which Prevent TCD Procedure
Patient Who Requires Continuous Medication With Alpha Blocking Agents
Concurrent Usage Of Acei
Poor Mental Function Or Any Other Reason To Expect Difficulty In Meeting The Requirements Of The Study
Concurrent Treatment With Other Lipid-Lowering Drug
Childbearing Potential Women Not Undergoing Adequate Contraceptive Control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)
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