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NCT Number: NCT07543120

An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Suita, Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent must be obtained prior to participation in the study.
  • Successful completion of treatment period on QCZ484 study medication in parent study.
  • 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:

  • Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
  • 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.
  • Permanent or persistent atrial fibrillation developed during the parent study.
  • Clinically significant valvular heart disease developed during the parent study.
  • 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

Treatment and study plan

QCZ484

Drug

QCZ484 subcutaneous injection, Q6M.

Primary outcomes

  1. Number of participants with AEs

    Time frame: Up to 66 months

    Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs

Secondary outcomes

  1. Change in SBP and DBP assessed by ambulatory blood pressure monitoring

    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

  2. Change in SBP and DBP assessed by office blood pressure measurement

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 21, 2026
Registry last updated
Jul 30, 2026

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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