A Phase 2 interventional study of Saline and QCZ484 in Hypertension, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 73 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Other
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
Phase 2b, multicenter, randomized, double-blind, placebo-controlled, 12 months treatment study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 396 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:
Other protocol-defined inclusion/exclusion criteria may apply
Placebo
Other: Saline
QCZ484 Dose 1 solution for injection
Drug: QCZ484
QCZ484 Dose 2 solution for injection
Drug: QCZ484
QCZ484 Dose 3 solution for injection
Drug: QCZ484
QCZ484 Dose 4 solution for injection
Drug: QCZ484
QCZ484 Dose 5 solution for injection
Drug: QCZ484
0.9% sodium chloride saline solution
Solution of Injection
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
Time frame: Baseline, Month 3
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 6 in mean 24hr SBP by ABPM
Time frame: Baseline, Month 6
Change in SBP by OBPM
Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Time frame: Baseline, Month 3 and 6
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
Proportion of responders defined as participants achieving SBP\<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Time frame: Baseline, Month 3 and 6
Change in DBP by ABPM and OBPM
Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Time frame: Baseline, Month 3 and 6
Number of participants with AEs
Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.
Time frame: Up to Month 18
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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals