Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 46
- 主要终点
- Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
研究概览
简要总结
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis
- •Exertional symptoms including at least one of the following:
- •New York Heart Association (NYHA) Class ≥ II dyspnea
- •Canadian Cardiovascular Society (CCS) Class ≥ II angina
- •Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight
- •Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)
排除标准
- •Known aortic valve stenosis (moderate or severe)
- •Known coronary artery disease
- •Left ventricular systolic dysfunction (ejection fraction < 50%)
- •Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Eleclazine
Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.
干预措施: Eleclazine (Drug)
Placebo
Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
干预措施: Eleclazine (Drug)
Placebo
Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24
时间窗: Baseline to Week 24
次要结局
- Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12(Baseline to Week 12)
- Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12(Baseline to Week 12)
- Change in Treadmill Exercise Time From Baseline to Week 12(Baseline to Week 12)
- Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24(Baseline to Week 24)
- Change in Treadmill Exercise Time From Baseline to Week 24(Baseline to Week 24)