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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325637
• Other study ID #: CNL-BR3-01-02
• Secondary ID: CHERISH Study
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2006
• Last updated: December 11, 2008
• Start date: January 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2008
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ischemic stroke patients with hypertension

Exclusion Criteria:

• Cardioembolic stroke patients

• Severe hypertensive patients

• Secondary hypertensive patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Stroke

Intervention

Drug:
• cilnidipine
Cilnidipine 10~20mg, qd, po for 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Budang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of global cerebral blood flow		from screnning to weeks 4	No
Secondary	The percentile change of regional CBF		from screnning to weeks 4	No
Secondary	The proportion of patients less than 8.6% decrease of global CBF		from screnning to weeks 4	No
Secondary	The change of NIHSS scores		from screnning to weeks 4	No

External Links

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