Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
|ClinicalTrials.gov Identifier: NCT00325637|
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : December 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Stroke||Drug: cilnidipine||Phase 3|
Design: Multi-center, randomized, double-blind, active control, titrated dose, non-inferiority trial
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Center, Double Blind, Randomized and Non-Inferiority Clinical Study of Cilnidipine to Compare the Effects on Cerebral Blood Flow With Losartan in Patients With Ischemic Stroke Hypertension|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||August 2007|
Active Comparator: 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 10~20mg, qd, po for 4 weeks.
- the changes of global cerebral blood flow [ Time Frame: from screnning to weeks 4 ]
- The percentile change of regional CBF [ Time Frame: from screnning to weeks 4 ]
- The proportion of patients less than 8.6% decrease of global CBF [ Time Frame: from screnning to weeks 4 ]
- The change of NIHSS scores [ Time Frame: from screnning to weeks 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325637
|Korea, Republic of|
|Seoul National University Budang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of|
|Principal Investigator:||Seong H Park, Professor||Seoul National University Budang Hospital|
|Principal Investigator:||Jeong H Rha, Professor||Inha University Hospital|
|Principal Investigator:||Ja S Koo, Professor||Eulji General Hospital|
|Principal Investigator:||Keun S Hong, Professor||Inje University|
|Principal Investigator:||Yong S Lee, Professor||Seoul National University Boramae Hospital|
|Principal Investigator:||Dong W Kang, Assistant Professor||Asan Medical Center|