A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 323
- 试验地点
- 25
- 主要终点
- Number of participants with AEs
研究概览
简要总结
The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols.
详细描述
This is a single arm, multicenter, OLE study designed to evaluate long-term safety, tolerability and efficacy of QCZ484, administered SC, once Q6M, in patients with HTN, who have successfully completed treatment period in the parent studies of the QCZ484 HTN program.
Participants at sites from the parent study will be offered the option to enroll in this extension study at the Month 12 visit upon successful completion of the parent study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent must be obtained prior to participation in the study.
- •Successful completion of treatment period on QCZ484 study medication in parent study.
- •No significant safety issue that may place participant at safety risk as determined by the Investigator.
排除标准
- •Participants meeting any of the following criteria, may it be pre-existing or developed during the parent study, are not eligible for inclusion in this study:
- •Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
- •Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade atrioventricular (AV) block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) developed during the parent study.
- •Permanent or persistent atrial fibrillation developed during the parent study.
- •Clinically significant valvular heart disease developed during the parent study.
- •Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) developed during the parent study. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to enrollment.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QCZ484
QCZ484 administered subcutaneously (SC) Q6M
干预措施: QCZ484 (Drug)
结局指标
主要结局
Number of participants with AEs
时间窗: Up to 66 months
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
次要结局
- Change in SBP and DBP assessed by ambulatory blood pressure monitoring(Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study))
- Change in SBP and DBP assessed by office blood pressure measurement(Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study))