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

This study has been completed.
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00754429
First received: September 16, 2008
Last updated: October 22, 2013
Last verified: October 2013

September 16, 2008
October 22, 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00754429 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00754429
2008_025, MK0954-338
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