QCZ484 extension for hypertensive patients after parent study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multicenter extension assessing QCZ484 safety, tolerability, and efficacy over long term in hypertensive patients who completed prior QCZ484 studies. Participants receive QCZ484 subcutaneously every six months. The study collects ongoing safety data and evaluates whether blood pressure control is maintained or improved in the extension setting. Enrollment is offered to eligible participants who completed the parent study, with continued monitoring at ongoing study visits.

Why it matters

Who can join: the full rules

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

Where it's running

• NICRs Research Center
  Garden Grove, California, United States Recruiting
• Downtown L A Research Center Inc
  Los Angeles, California, United States Recruiting
• Clinical Research of Brandon LLC
  Brandon, Florida, United States Recruiting
• Entrust Clinical Research
  Miami, Florida, United States Recruiting
• Inpatient Research Clinical LLC
  Miami Lakes, Florida, United States Recruiting
• American Research Centers of FL
  Pembroke Pines, Florida, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.