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NCT07543120
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
Conditions: Hypertension (HTN)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 323
Sponsor: Novartis Pharmaceuticals
Location: NICRs Research Center Garden Grove California
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 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
Source: ClinicalTrials.gov (NCT07543120). StuddyBuddy aggregates publicly available trial information.