EUCTR2007-004890-24-FR进行中（未招募）不适用
A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEH
Juvantia Pharma Ltd0 个研究点目标入组 24 人开始时间: 2008年5月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients = 30 and < 80 years of age with an intact oral
- •mucosa at screening
- •Diagnosis of MSA or diagnosis of idiopathic PD
- •Hoehn and Yahr stages 1 to 4 during ‘Off’ period
- •NOH: reproducible fall in SBP = 20 mmHg and/or a fall in DBP = 10 mmHg
- •between 15 min of supine rest and 3 min of standing (or until symptomatic
- •from hypotension after < 3 min of standing)
- •For patient taking antiparkinsonian medication: stable daily dosing for at
- •least 1 month
- •For patient taking fludrocortisone: stable dose for at least 2 months
- •Demonstrated ability to comprehend, give informed consent and comply
- •with study procedures (BP self-monitoring, completion of patient diary and
- •self-assessment rating scales)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other clinically significant conditions apart from those typically associated
- •with MSA or PD
- •SBP = 200 mmHg or DBP = 120 mmHg after 15 min supine rest in quiet
- •environment
- •Clinically significant abnormalities of ECG
- •Mini-Mental State Examination (MMSE) score < 24
- •Intake of prohibited concomitant medication (Appendix C), such as
- •midodrine, intake of medication associated with vasodilatation or induction of
- •liver enzymes; neuroleptics; certain drugs known to be substantially
- •metabolized through the following cytochrome P450 isoenzymes: 1A2, 2B6,
- •2C19, 2C9, 2D6 and 2E1; or any other drug for the treatment of orthostatic
- •hypotension (including off-label use), such as non-steroidal antiinflammatory
- •drugs, beta blockers, somatostatin
- •Use of St. John’s Wort or Ginkgo Biloba within 48 h prior to inclusion and
- •during the course of the study
- •Intake of an investigational drug within 30 days prior to screening
研究者
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