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CompletedNCT00754429Updated Oct 23, 2013

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

A Phase 4 interventional study of losartan and amlodipine in Ischemic Stroke, sponsored by Taipei Veterans General Hospital, Taiwan. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-10-23.

Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    A

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

    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.

    Drug: amlodipine

Interventions

  • Druglosartan

    losartan 50mg qd for 30 weeks.

    Also known as: losartan potassium, COZAAR®, MK0954

  • Drugamlodipine

    amlodipine 5 mg q.d for 30 weeks.

    Also known as: Norvasc

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00754429
Lead sponsor
Taipei Veterans General Hospital, Taiwan
First posted
Sep 18, 2008
Start date
Jun 2004
Primary completion
Jun 2009
Completion
Jul 2009
Last update
Oct 23, 2013

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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