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

Last updated: December 11, 2008
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Williams Syndrome

Stroke

Treatment

N/A

Clinical Study ID

NCT00325637
CNL-BR3-01-02
CHERISH Study
  • Ages 35-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ischemic stroke patients with hypertension

Exclusion

Exclusion Criteria:

  • Cardioembolic stroke patients

  • Severe hypertensive patients

  • Secondary hypertensive patients

Study Design

Total Participants: 250
Study Start date:
January 01, 2005
Estimated Completion Date:
August 31, 2007

Study 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.

Connect with a study center

  • Seoul National University Budang Hospital

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

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