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Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension

Primary Purpose

Hypertension, Stroke

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cilnidipine
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring CHERISH, Ischemic Stroke

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ischemic stroke patients with hypertension Exclusion Criteria: Cardioembolic stroke patients Severe hypertensive patients Secondary hypertensive patients

Sites / Locations

  • Seoul National University Budang Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A,1,III

Arm Description

To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke

Outcomes

Primary Outcome Measures

the changes of global cerebral blood flow

Secondary Outcome Measures

The percentile change of regional CBF
The proportion of patients less than 8.6% decrease of global CBF
The change of NIHSS scores

Full Information

First Posted
May 11, 2006
Last Updated
December 11, 2008
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00325637
Brief Title
Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Stroke
Keywords
CHERISH, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A,1,III
Arm Type
Active Comparator
Arm Description
To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke
Intervention Type
Drug
Intervention Name(s)
cilnidipine
Other Intervention Name(s)
Arms: Losartan, Cilnidipine, Cinalong
Intervention Description
Cilnidipine 10~20mg, qd, po for 4 weeks.
Primary Outcome Measure Information:
Title
the changes of global cerebral blood flow
Time Frame
from screnning to weeks 4
Secondary Outcome Measure Information:
Title
The percentile change of regional CBF
Time Frame
from screnning to weeks 4
Title
The proportion of patients less than 8.6% decrease of global CBF
Time Frame
from screnning to weeks 4
Title
The change of NIHSS scores
Time Frame
from screnning to weeks 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic stroke patients with hypertension Exclusion Criteria: Cardioembolic stroke patients Severe hypertensive patients Secondary hypertensive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong H Park, Professor
Organizational Affiliation
Seoul National University Budang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong H Rha, Professor
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ja S Koo, Professor
Organizational Affiliation
Eulji General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keun S Hong, Professor
Organizational Affiliation
Inje University Ilsan Paik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong S Lee, Professor
Organizational Affiliation
Seoul National University Boramae Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong W Kang, Assistant Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Budang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension

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