NCT03153137已完成3 期
Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects
Actelion32 个研究点 分布在 12 个国家目标入组 142 人开始时间: 2017年8月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 32
- 主要终点
- Change From Baseline in Peak Oxygen Uptake/Consumption (VO2) Up to Week 16
研究概览
简要总结
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures
- •Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
- •New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
- •Women of childbearing potential must have a negative serum pregnancy test use reliable contraception
排除标准
- •Pattern of Fontan circulation severity
- •Deterioration of the Fontan-palliated condition.
- •Limitations to Cardiopulmonary exercise testing (CPET)
- •Peak VO2 < 15 mL/kg/min.
- •Any known factor or disease that may interfere with treatment compliance or full participation in the study
研究组 & 干预措施
Macitentan
Experimental
Macitentan 10 mg per day; film-coated tablet; oral use
干预措施: Macitentan 10 mg (Drug)
Placebo
Placebo Comparator
film-coated tablet; oral use
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Peak Oxygen Uptake/Consumption (VO2) Up to Week 16
时间窗: Baseline up to Week 16
Change from baseline in peak VO2 up to Week 16 was reported.
次要结局
- Change From Baseline in Mean Count Per Minute of Daily Physical Activity Measured by Accelerometer (PA-Ac) Up to Week 16(Baseline up to Week 16)
- Number of Participants With AEs Leading to Premature Discontinuation of Study Treatment(Up to 56 weeks)
- Change From Baseline in Erythrocytes and Reticulocytes(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Gamma Glutamyl Transferase(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Albumin and Protein(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Peak VO2 Up to Week 52(Baseline up to Week 52)
- Change From Baseline in Hemoglobin(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Hematocrit(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Bilirubin and Direct Bilirubin(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Creatinine(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Urate(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Cystatin C(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)(Up to 56 weeks)
- Change From Baseline in Pulse Rate(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelets(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (AP)(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Glucose, Cholesterol, Triglycerides, Sodium, Potassium, Chloride and Calcium(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Alpha Fetoprotein(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Number of Participants With Treatment-emergent Adverse Events (AEs)(Up to 56 weeks)
- Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP)(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Oxygen Saturation (SpO2)(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Body Weight(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Values(Up to 56 weeks)
- Change From Baseline in Prothrombin International Normalized Ratio(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Prothrombin Time(Baseline, Week 8, Week 16, Week 32 and Week 52)
- Change From Baseline in Urea Nitrogen(Baseline, Week 8, Week 16, Week 32 and Week 52)
研究者
研究点 (32)
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