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

Ischemic Stroke Clinical Trial

Official title:

The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754429
• Other study ID #: 2008_025
• Secondary ID: MK0954-338
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: October 22, 2013
• Start date: June 2004
• Est. completion date: July 2009

Study information

• Verified date: October 2013
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• losartan
losartan 50mg qd for 30 weeks.
• amlodipine
amlodipine 5 mg q.d for 30 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No