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A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients (CQCZ484A12203B)

An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients (CQCZ484A12203B)

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Recruiting

June. 16, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Signed informed consent must be obtained prior to participation in the study.
2. Successful completion of treatment period on QCZ484 study medication in parent study.
3. No significant safety issue that may place participant at safety risk as determined by the Investigator.

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:

1. Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
2. 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.
3. Permanent or persistent atrial fibrillation developed during the parent study.
4. Clinically significant valvular heart disease developed during the parent study.
5. 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.

Both

Hypertension

Drug: QCZ484
QCZ484 subcutaneous injection, Q6M

Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs up to 66 months

+81-3-5050-4268

May. 20, 2026

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

United States/Singapore