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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00325637
Enrollment
250
Registered
2006-05-15
Start date
2005-01-31
Completion date
2007-08-31
Last updated
2008-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Stroke

Keywords

CHERISH, Ischemic Stroke

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.

Interventions

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

Sponsors

Boryung Pharmaceutical Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Ischemic stroke patients with hypertension

Exclusion criteria

* Cardioembolic stroke patients * Severe hypertensive patients * Secondary hypertensive patients

Design outcomes

Primary

MeasureTime frame
the changes of global cerebral blood flowfrom screnning to weeks 4

Secondary

MeasureTime frame
The percentile change of regional CBFfrom screnning to weeks 4
The proportion of patients less than 8.6% decrease of global CBFfrom screnning to weeks 4
The change of NIHSS scoresfrom screnning to weeks 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026