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

NCT00754429 | Completed Phase 4

• 2 other identifiers: 2008_025MK0954-338
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke patients.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30.

  At week 0, week 6, week 18 and week 30.

Study Arms (2)

A

EXPERIMENTAL

Losartan 50mg qd for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.

Drug: losartan

B

ACTIVE COMPARATOR

Amlodipine 5 mg q.d for 30 weeks, if blood pressure \> 140/90, or mean arterial Bp ≧ 15% of baseline, then add on diuretics.

Drug: amlodipine

Interventions

losartan DRUG

losartan 50mg qd for 30 weeks.

Also known as: losartan potassium, COZAAR®, MK0954

A

amlodipine DRUG

amlodipine 5 mg q.d for 30 weeks.

Also known as: Norvasc

B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Losartan; Amlodipine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: June 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 23, 2013

Record last verified: 2013-10