The Effect of Losartan Versus Amlodipine-Based Therapy in Ischemic Stroke
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Stroke
Intervention: losartan (Drug); amlodipine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To compare the effect of losartan vs amlodipine-based antihypertensive therapy on
atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke
patients.
Clinical Details
Official title: The Effect of Losartan Versus Amlodipine-Based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Merck Sharp & Dohme (I.A.) Corp., Taipei [106, Taiwan; Recruiting
Sam Lim, Phone: 65-6305-8424
Additional Information
Starting date: June 2004
Last updated: January 8, 2009
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