RecruitingPhase 2NCT07543120

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

323 participants

Start Date

May 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria6

  • 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.

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Interventions

DRUGQCZ484

QCZ484 subcutaneous injection, Q6M.


Locations(7)

NICRs Research Center

Garden Grove, California, United States

Entrust Clinical Research

Miami, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Javara Research

Fayetteville, Georgia, United States

Anderson Medical Research

Ft. Washington, Maryland, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Novartis Investigative Site

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT07543120


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