NL-OMON52672尚未招募2 期
A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy - 0771/0032 (Cytokinetics CY 6021)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Males and females between 18 and 85 years of age at Screening.
- •Body weight is >=45 kg at Screening.
- •Diagnosed with HCM per the following criteria:
- •Has LV hypertrophy with non-dilated LV chamber in the absence of other
- •cardiac disease.
- •Has minimal wall thickness >=15 mm (minimal wall thickness >=13 mm is
- •acceptable with a positive family history of HCM or with a known
- •disease-causing gene mutation).
- •Adequate acoustic windows for echocardiography.
- •For Cohorts 1,2 and 3 has LVOT-G during screening as follows:
- •Resting gradient >=50 mmHg
- •Resting gradient >=30 mmHg and <50 mmHg with post-Valsalva LVOT G >=50 mmHg
- •LVEF >=60% at screening.
- •New York Heart Association (NYHA) Class II or III at Screening.
- •Patients on beta-blockers, verapamil, diltiazem, or ranolazine should have been
- •on stable doses for >4 weeks prior to Randomization and anticipate remaining on
- •the same medication regimen during the study.
- •For Cohort 3: Patients must be taking disopyramide. Patients should have been
- •on stable disopyramide doses for >4 weeks prior to screening and anticipate
- •remaining on the same medication regimen during the study.
- •For Cohort 4 has resting and post-Valsalva LVOT-G <30 mmHg at the time of
- •For Cohort 4 has elevated NT-proBNP >300 pg/mL at the time of screening.
- •A full listing can be found in Protocol section 5.
排除标准
- •- Aortic stenosis or fixed subaortic obstruction.
- •- Known infiltrative or storage disorder causing cardiac hypertrophy that
- •mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
- •- History of LV systolic dysfunction (LVEF <45%) at any time during their
- •clinical course.
- •- Documented history of current obstructive coronary artery disease (>70%
- •stenosis in one or more epicardial coronary arteries) or documented history of
- •myocardial infarction.
- •- Has been treated with septal reduction therapy (surgical myectomy or
- •percutaneous alcohol septal ablation) or has plans for either treatment during
- •the study period (Cohorts 1, 2, and 3 only). Patients having undergone septal
- •reduction therapy > 12 months prior to screening who remain symptomatic from
- •nHCM, and who meet all other criteria for inclusion, may be enrolled in Cohort
- •- For Cohorts 1, 2 and 4: Has been treated with disopyramide or antiarrhythmic
- •drugs that have negative inotropic activity within 4 weeks prior to screening.
- •For Cohort 3, use of disopyramide is required.
- •- Paroxysmal atrial fibrillation or flutter documented during the Screening
- •- Paroxysmal or permanent atrial fibrillation requiring rhythm restoring
- •treatment (eg, direct-current cardioversion, ablation procedure, or
- •antiarrhythmic therapy) <=6 months prior to screening. (This exclusion does not
- •apply if atrial fibrillation has been treated with anticoagulation and
- •adequately rate-controlled for >6 months.)
- •- History of syncope or sustained ventricular tachyarrhythmia with exercise
- •within 6 months prior to Screening.
- •- Has received prior treatment with CK3773274 or is currently receiving
- •mavacamten.
- •- For Cohort 4: has any documented history of LVOT-G >= 30 mmHg at rest, with
- •Valsalva, or with exercise (for subjects who have had prior septal reduction
- •therapy, this exclusion criteria only applies to gradients detected following
- •septal reduction therapy).
研究者
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