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Completed

NCT Number: NCT00325637

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

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.

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Key information

Conditions

Hypertension Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Budang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic stroke patients with hypertension

Exclusion criteria

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

Treatment and study plan

cilnidipine

Drug

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

Other names: Arms: Losartan, Cilnidipine, Cinalong

Primary outcomes

  1. the changes of global cerebral blood flow

    Time frame: from screnning to weeks 4

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 15, 2006
Registry last updated
Dec 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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