Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
NCT ID: NCT00325637
Last Updated: 2008-12-12
Study Results
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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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2005-01-31
2007-08-31
Brief Summary
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Detailed Description
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Population Studied: We will prospectively recruit 250 hypertensive patients who had ischemic stroke 2 or more weeks previously and were admitted at 7 centers in the Seoul metropolitan area in South Korea.
Interventions: After a 2-week washout period, all patients will undergo baseline 99mTc-HMPAO single photon emission computed tomography (SPECT), blood pressure evaluation, NIHSS examination, and laboratory test prior to treatment. The patients will be randomized to receive either cilnidipine 10-20mg or losartan 50-100mg once daily for 4 weeks with a target systolic blood pressure of \< 140mmHg and diastolic blood pressure of \< 90mmHg. After 4-week treatment, all patients will receive follow-up SPECT and blood pressure evaluation. For the quantitative CBF analysis, SPECT will be performed with a single machine in one center.
Outcome Measures: Primary outcome measure is the percentile change of global CBF on SPECT between pre- and post-treatments. Secondary outcome measures include the percentile change of regional CBF, the proportion of patients less than 8.6% decrease of global CBF, and the change of NIHSS score.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A,1,III
To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke
cilnidipine
Cilnidipine 10\~20mg, qd, po for 4 weeks.
Interventions
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cilnidipine
Cilnidipine 10\~20mg, qd, po for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe hypertensive patients
* Secondary hypertensive patients
35 Years
80 Years
ALL
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Boryung Pharmaceutical Co., Ltd
Principal Investigators
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Seong H Park, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Budang Hospital
Jeong H Rha, Professor
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Ja S Koo, Professor
Role: PRINCIPAL_INVESTIGATOR
Eulji General Hospital
Keun S Hong, Professor
Role: PRINCIPAL_INVESTIGATOR
Inje University Ilsan Paik Hospital
Yong S Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Boramae Hospital
Dong W Kang, Assistant Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Seoul National University Budang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CHERISH Study
Identifier Type: -
Identifier Source: secondary_id
CNL-BR3-01-02
Identifier Type: -
Identifier Source: org_study_id