NCT00004268已完成2 期
Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension
National Center for Research Resources (NCRR)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension.
II. Assess the quality of life in these patients with this treatment regimen.
详细描述
PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8.
Quality of life is assessed at weeks 3, 6, and 8.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
排除标准
- 未提供
研究者
研究点 (1)
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