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

NCT07543120 · Novartis
In plain English

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Official title
A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.
About this study
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.
Eligibility criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Other protocol-defined inclusion/exclusion criteria may apply
Study design
Enrollment target: 323 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-07
Estimated completion: 2031-11-30
Last updated: 2026-06-01
Interventions
Drug: QCZ484
Primary outcomes
  • Number of participants with AEs (Up to 66 months)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (7)
NICRs Research CenterRecruiting
Garden Grove, California, United States
Entrust Clinical ResearchRecruiting
Miami, Florida, United States
Inpatient Research Clinical LLCRecruiting
Miami Lakes, Florida, United States
Javara ResearchRecruiting
Fayetteville, Georgia, United States
Anderson Medical ResearchRecruiting
Ft. Washington, Maryland, United States
Monroe Biomedical ResearchRecruiting
Monroe, North Carolina, United States
Novartis Investigative SiteRecruiting
Singapore, Singapore
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients. · TrialPath