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

NCT ID: NCT00754429

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

losartan

Intervention Type DRUG

losartan 50mg qd for 30 weeks.

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.

Group Type ACTIVE_COMPARATOR

amlodipine

Intervention Type DRUG

amlodipine 5 mg q.d for 30 weeks.

Interventions

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losartan

losartan 50mg qd for 30 weeks.

Intervention Type DRUG

amlodipine

amlodipine 5 mg q.d for 30 weeks.

Intervention Type DRUG

Other Intervention Names

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losartan potassium COZAAR® MK0954 Norvasc

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Merck & Co., Inc.

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Taiwan

Other Identifiers

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MK0954-338

Identifier Type: -

Identifier Source: secondary_id

2008_025

Identifier Type: -

Identifier Source: org_study_id