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Trial record 2 of 2 for:    CHERISH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00325637
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : December 12, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Stroke Drug: cilnidipine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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
Drug: cilnidipine
Cilnidipine 10~20mg, qd, po for 4 weeks.
Other Names:
  • Arms: Losartan, Cilnidipine
  • Cinalong

Primary Outcome Measures :
  1. the changes of global cerebral blood flow [ Time Frame: from screnning to weeks 4 ]

Secondary Outcome Measures :
  1. The percentile change of regional CBF [ Time Frame: from screnning to weeks 4 ]
  2. The proportion of patients less than 8.6% decrease of global CBF [ Time Frame: from screnning to weeks 4 ]
  3. The change of NIHSS scores [ Time Frame: from screnning to weeks 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ischemic stroke patients with hypertension

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325637

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Korea, Republic of
Seoul National University Budang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
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Principal Investigator: Seong H Park, Professor Seoul National University Budang Hospital
Principal Investigator: Jeong H Rha, Professor Inha University Hospital
Principal Investigator: Ja S Koo, Professor Eulji General Hospital
Principal Investigator: Keun S Hong, Professor Inje University
Principal Investigator: Yong S Lee, Professor Seoul National University Boramae Hospital
Principal Investigator: Dong W Kang, Assistant Professor Asan Medical Center

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Responsible Party: Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd Identifier: NCT00325637     History of Changes
Other Study ID Numbers: CNL-BR3-01-02
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Ischemic Stroke

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs