QCZ484
DrugQCZ484 subcutaneous injection, Q6M.
NCT Number: NCT07543120
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Novartis Investigative Site, Suita, Osaka, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 subcutaneous injection, Q6M.
Time frame: Up to 66 months
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Time frame: Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
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 66 (OLE study)
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)
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
CONTACT
Novartis Pharmaceuticals
CONTACT
Novartis Pharmaceuticals
Industry
A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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