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

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00325637
First received: May 11, 2006
Last updated: December 11, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Hypertension
Stroke
Drug: cilnidipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • the changes of global cerebral blood flow [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentile change of regional CBF [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
  • The proportion of patients less than 8.6% decrease of global CBF [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
  • The change of NIHSS scores [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: January 2005
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke patients with hypertension

Exclusion Criteria:

  • Cardioembolic stroke patients
  • Severe hypertensive patients
  • Secondary hypertensive patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325637

Locations
Korea, Republic of
Seoul National University Budang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00325637     History of Changes
Other Study ID Numbers: CNL-BR3-01-02, CHERISH Study
Study First Received: May 11, 2006
Last Updated: December 11, 2008
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Cilnidipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 31, 2014