Actively Recruiting
A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients
Led by Novartis Pharmaceuticals · Updated on 2026-06-01
323
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety, tolerability, and effectiveness of QCZ484 in adults with hypertension who have completed previous QCZ484 studies. The trial focuses on patients who successfully finished treatment in parent studies, providing additional information on QCZ484's impact over an extended period. The study is conducted as a phase 2, open-label extension across multiple centers. Participants receive QCZ484 through subcutaneous injections every six months. This single-group study invites eligible patients from prior trials to join during their 12-month visit after completing the earlier treatment phase. The design allows monitoring of QCZ484's effects over a long timeframe in a real-world setting. During participation, individuals undergo regular assessments including ambulatory and office blood pressure measurements, which are compared from baseline in the parent study through up to 60-66 months in this extension. Researchers track adverse events closely over up to 66 months to evaluate safety. The study lasts several years, with continuous monitoring to support comprehensive safety and efficacy data collection.
CONDITIONS
Brief Title
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained before participation
- Successful completion of QCZ484 treatment in the parent study
- No significant safety concerns as assessed by the investigator
You will not qualify if you...
- Evidence of liver disease risking long-term QCZ484 use as judged by the investigator
- Clinically significant cardiac arrhythmias or high-grade AV block developed during parent study
- Permanent or persistent atrial fibrillation developed during parent study
- Clinically significant valvular heart disease developed during parent study
- Acute myocardial infarction, unstable angina, coronary intervention, or stroke history prior to enrollment
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 66 months
Participants receive QCZ484 subcutaneous injections once every 6 months to assess long-term safety, tolerability, and efficacy.
Visits every 6 months for injections and monitoring
Trial Site Locations
Total: 7 locations
1
NICRs Research Center
Garden Grove, California, United States, 92844
Actively Recruiting
2
Entrust Clinical Research
Miami, Florida, United States, 33176
Actively Recruiting
3
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
4
Javara Research
Fayetteville, Georgia, United States, 30214
Actively Recruiting
5
Anderson Medical Research
Ft. Washington, Maryland, United States, 20744
Actively Recruiting
6
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
7
Novartis Investigative Site
Singapore, Singapore, 529889
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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