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The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754429
First Posted: September 18, 2008
Last Update Posted: October 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Veterans General Hospital, Taiwan
September 16, 2008
September 18, 2008
October 23, 2013
June 2004
June 2009   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT00754429 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)
The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients
To compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke patients.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: losartan
    losartan 50mg qd for 30 weeks.
    Other Names:
    • losartan potassium
    • COZAAR®
    • MK0954
  • Drug: amlodipine
    amlodipine 5 mg q.d for 30 weeks.
    Other Name: Norvasc
  • Experimental: A
    Losartan 50mg qd for 30 weeks, if blood pressure > 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.
    Intervention: Drug: losartan
  • Active Comparator: B
    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: Drug: amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Taiwan
 
NCT00754429
2008_025
MK0954-338
Not Provided
Not Provided
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Taipei Veterans General Hospital, Taiwan
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Taipei Veterans General Hospital, Taiwan
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP