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JAPANESE
JRCT ID: jRCT2031260200

Registered date:05/06/2026

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment16/06/2026
Target sample size51
Countries of recruitment
Study typeInterventional
Intervention(s)Drug: QCZ484 QCZ484 subcutaneous injection, Q6M

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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.
Exclude criteriaParticipants 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.

Related Information

Contact

Public contact
Name Kyosuke Yamauchi
Address Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333
Telephone +81-120-003-293
E-mail rinshoshiken.toroku@novartis.com
Affiliation Novartis Pharma. K.K.
Scientific contact
Name Kyosuke Yamauchi
Address Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333
Telephone +81-120-003-293
E-mail rinshoshiken.toroku@novartis.com
Affiliation Novartis Pharma. K.K.