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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Hypertension Stroke

Keywords

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CHERISH Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

cilnidipine

Intervention Type DRUG

Cilnidipine 10\~20mg, qd, po for 4 weeks.

Interventions

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cilnidipine

Cilnidipine 10\~20mg, qd, po for 4 weeks.

Intervention Type DRUG

Other Intervention Names

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Arms: Losartan, Cilnidipine Cinalong

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke patients with hypertension

Exclusion Criteria

* Cardioembolic stroke patients
* Severe hypertensive patients
* Secondary hypertensive patients
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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South Korea

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