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

Phase 3

Completed

• Conditions: Stroke; Hypertension
• Interventions: Drug: cilnidipine

• Registration Number: NCT00325637
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-15
• Primary Completion: 2007-07
• Study Completion: 2007-08
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-11
• Last Update Posted: 2008-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Ischemic stroke patients with hypertension

Exclusion Criteria

• Cardioembolic stroke patients
• Severe hypertensive patients
• Secondary hypertensive patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,1,III	cilnidipine	To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke

Primary Outcome Measures

Name	Time	Method
the changes of global cerebral blood flow	from screnning to weeks 4

Secondary Outcome Measures

Name	Time	Method
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
The percentile change of regional CBF	from screnning to weeks 4

Trial Locations

Locations (1)

Seoul National University Budang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of