NCT01927055终止3 期
A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Chelsea Therapeutics3 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
研究概览
简要总结
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
详细描述
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •18 years and older and ambulatory (defined as able to walk at least 10 meters);
- •Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency;
- •At the Baseline visit (Visit 2), patients must demonstrate:
- •a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1;
- •a fall of at least 20 mmHg in their systolic blood pressure, within 3 minutes of standing;
- •Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care;
排除标准
- •Score of 23 or lower on the mini-mental state examination (MMSE);
- •Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;
- •Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study;
- •Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse);
- •Women who are pregnant or breastfeeding;
- •Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner;
- •Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception;
- •Untreated closed angle glaucoma;
- •Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine HTN are allowed in this study) Any significant uncontrolled cardiac arrhythmia;
- •History of myocardial infarction, within the past 2 years;
- •Current unstable angina;
- •Congestive heart failure (NYHA Class 3 or 4);
- •History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ;
- •Gastrointestinal condition that may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass);
- •Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2);
- •Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2);
- •Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2);
- •Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study;
- •The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.
研究组 & 干预措施
Droxidopa
Active Comparator
Droxidopa 100 mg, 200 mg, 300 mg
干预措施: Droxidopa (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
时间窗: Change from Randomization to Week 1
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.
次要结局
未报告次要终点
研究者
研究点 (3)
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