An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

Официальное название

A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат QCZ484
  QCZ484 subcutaneous injection, Q6M.

Первичные конечные точки

• Number of participants with AEs [Срок оценки: Up to 66 months]

Вторичные конечные точки (2)

• Change in SBP and DBP assessed by ambulatory blood pressure monitoring [Срок оценки: 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 [Срок оценки: Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 19 центров

• NICRs Research Center — Garden Grove
• Downtown L A Research Center Inc — Los Angeles
• Clinical Research of Brandon LLC — Brandon
• Entrust Clinical Research — Miami
• Inpatient Research Clinical LLC — Miami Lakes
• American Research Centers of FL — Pembroke Pines
• Cen Exel FCR — Tampa
• Cardiology Partners Clinical Research Institute — Wellington
• … и ещё 11 центров

Япония · 4 центра

• Novartis Investigative Site — Suita
• Novartis Investigative Site — Chuo Ku
• Novartis Investigative Site — Chuo-ku
• Novartis Investigative Site — Shinjuku Ku

Сингапур · 2 центра

• Novartis Investigative Site — Singapore
• Novartis Investigative Site — Singapore

Идентификаторы

NCT: NCT07543120 · CQCZ484A12203B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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