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

July 29, 2026 updated by: Novartis Pharmaceuticals

A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

323

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650853
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0031
        • Recruiting
        • Novartis Investigative Site
      • Chuo-ku, Tokyo, Japan, 1030027
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0008
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Recruiting
        • Novartis Investigative Site
  • United States
    • California
      • Garden Grove, California, United States, 92844
        • Recruiting
        • NICRs Research Center
        • Principal Investigator:
          • Mallu Reddy
        • Contact:
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Downtown L A Research Center Inc
        • Contact:
        • Principal Investigator:
          • Salil U Nadkarni
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Clinical Research of Brandon LLC
        • Principal Investigator:
          • German Alvarez
        • Contact:
      • Miami, Florida, United States, 33176
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinical LLC
        • Principal Investigator:
          • Alexis Gutierrez
        • Contact:
      • Pembroke Pines, Florida, United States, 33027
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Cen Exel FCR
        • Principal Investigator:
          • Deborah White
        • Contact:
      • Wellington, Florida, United States, 33449
        • Recruiting
        • Cardiology Partners Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Neerav Suresh Shah
    • Georgia
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Javara Research
        • Principal Investigator:
          • William Cooper
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60621
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Maryland
      • Ft. Washington, Maryland, United States, 20744
    • Michigan
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research Center
        • Principal Investigator:
          • Jay Sandberg
        • Contact:
    • Missouri
      • Jefferson City, Missouri, United States, 65109
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Recruiting
        • CenExel HRI
        • Principal Investigator:
          • Kyle Coupe
        • Contact:
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Conrad Clinical Research
        • Principal Investigator:
          • Vicki Conrad
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Neuroscience Solutions Inc
        • Principal Investigator:
          • Lora J. McGill
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78205
        • Recruiting
        • Sun Research Institute
        • Principal Investigator:
          • Leonel Reyes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Successful completion of treatment period on QCZ484 study medication in parent study.
  3. 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:

  1. Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
  2. 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.
  3. Permanent or persistent atrial fibrillation developed during the parent study.
  4. Clinically significant valvular heart disease developed during the parent study.
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QCZ484
QCZ484 administered subcutaneously (SC) Q6M
Drug: QCZ484
QCZ484 subcutaneous injection, Q6M.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 66 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2026

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

November 30, 2031

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQCZ484A12203B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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