The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00754429

Purpose

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

Condition	Intervention	Phase
Ischemic Stroke	Drug: losartan Drug: amlodipine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	June 2004
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 losartan 50mg qd for 30 weeks.
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 amlodipine 5 mg q.d for 30 weeks.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754429

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_025, MK0954-338
Study First Received:	September 16, 2008
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00754429 History of Changes
Health Authority:	Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Calcium Channel Blockers
Central Nervous System Diseases
Cardiovascular Agents
Ischemia
Antihypertensive Agents

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Arrhythmia Agents
Brain Infarction

ClinicalTrials.gov processed this record on February 08, 2010