Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
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
2 other identifiers
interventional
250
1 country
1
Brief Summary
The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker) and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood pressure in hypertensive patients with a previous ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Jan 2005
Typical duration for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 11, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 12, 2008
December 1, 2008
2.5 years
May 11, 2006
December 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the changes of global cerebral blood flow
from screnning to weeks 4
Secondary Outcomes (3)
The percentile change of regional CBF
from screnning to weeks 4
The proportion of patients less than 8.6% decrease of global CBF
from screnning to weeks 4
The change of NIHSS scores
from screnning to weeks 4
Study Arms (1)
A,1,III
ACTIVE COMPARATORTo compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke
Interventions
Cilnidipine 10\~20mg, qd, po for 4 weeks.
Eligibility Criteria
You may qualify if:
- Ischemic stroke patients with hypertension
You may not qualify if:
- Cardioembolic stroke patients
- Severe hypertensive patients
- Secondary hypertensive patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Budang Hospital
Seongnam-si, Gyeonggi-do, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Ilsan Paik Hospital
- PRINCIPAL INVESTIGATOR
Yong S Lee, Professor
Seoul National University Boramae Hospital
- PRINCIPAL INVESTIGATOR
Dong W Kang, Assistant Professor
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2006
First Posted
May 15, 2006
Study Start
January 1, 2005
Primary Completion
July 1, 2007
Study Completion
August 1, 2007
Last Updated
December 12, 2008
Record last verified: 2008-12