An Open-label Extension Safety and Efficacy Study of QCZ4... | NCT07543120

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2026Actual

Primary Completion Date

May 31, 2031Estimated

Completion Date

Nov 30, 2031Estimated

First Submitted Date

Apr 15, 2026

First Submission Date that Met QC Criteria

Apr 15, 2026

First Posted Date

Apr 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

323Estimated

Label	Type	Description	Intervention Names
QCZ484	Experimental	QCZ484 administered subcutaneously (SC) Q6M	Drug: QCZ484

Name	Type	Description	Arm Group Labels	Other Names
QCZ484	Drug	QCZ484 subcutaneous injection, Q6M.	QCZ484

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with AEs	Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs	Up to 66 months

Secondary Outcomes

Measure	Description	Time Frame
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	Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Novartis Pharmaceuticals	Contact	1-888-669-6682		novartis.email@novartis.com
Novartis Pharmaceuticals	Contact	+41613241111

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NICRs Research Center	Recruiting	Garden Grove	California	92844	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases