A Phase 2 interventional study of QCZ484 in Hypertension (HTN), sponsored by Novartis Pharmaceuticals. Recruiting at 25 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 323 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Other protocol-defined inclusion/exclusion criteria may apply
QCZ484 administered subcutaneously (SC) Q6M
Drug: QCZ484
QCZ484 subcutaneous injection, Q6M.
Number of participants with AEs
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Time frame: Up to 66 months
Change in SBP and DBP assessed by ambulatory blood pressure monitoring
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline (parent study) and from Day 1 of the OLE and at Months 12 and so on (every 12 months) assessed by assessed by ambulatory blood pressure monitoring (ABPM) - applicable only for the subgroup of participants who had ABPM in the parent study
Time frame: Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
Change in SBP and DBP assessed by office blood pressure measurement
Change in SBP and DBP from Baseline (parent study) and from Day 1 of the OLE and at Months 6, 12 and so on (Q6M) assessed by assessed by office blood pressure measurement (OBPM)
Time frame: Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
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