Hypertension (HTN)Phase 2NCT07543120
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
A Phase 2 study testing QCZ484 in people with Hypertension (HTN), run by Novartis Pharmaceuticals at 25 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- QCZ484
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 7 May 2026to 30 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
25 sites in 3 countries
United States19 sites, 19 recruiting
- Recruiting
CenExel HRI
Berlin, New Jersey, 08009
Danielle Brudon, +1 856 452 9901#802, d.brudon@cenexel.com
Kyle Coupe
- Recruiting
Clinical Research of Brandon LLC
Brandon, Florida, 33511
Erika Santos, esantos@crofb.com
German Alvarez
- Recruiting
Eagle Clinical Research
Chicago, Illinois, 60621
Iesha Griffin, igriffin@eagleclinicalresearch.com
Olalekan Sowade
- Recruiting
Conrad Clinical Research
Edmond, Oklahoma, 73013
Shelly Todd, stodd@oktrials.com
Vicki Conrad
- Recruiting
Javara Research
Fayetteville, Georgia, 30214
Shemeka Williams, 229 518 4947, swilliams@javararesearch.com
William Cooper
- Recruiting
Anderson Medical Research
Ft. Washington, Maryland, 20744
Ann-Marie Cobb, andersonmedicalresearch@gmail.com
Felton Anderson
- Recruiting
NICRs Research Center
Garden Grove, California, 92844
Maria Murillo, +1 909 206 2454, mmurillo@nicresearch.com
Mallu Reddy
- Recruiting
Jefferson City Medical Group
Jefferson City, Missouri, 65109
Suzin Cunningham, suzin.cunningham@avacare.com
George Carr
- Recruiting
Downtown L A Research Center Inc
Los Angeles, California, 90017
Claudia Cisneros, +1 213 261 3680, ccisneros@dtlaresearch.com
Salil U Nadkarni
- Recruiting
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
Melissa Flowers, +1 901 843 1045, mflowers@cnshealthcare.com
Lora J. McGill
- Recruiting
Entrust Clinical Research
Miami, Florida, 33176
Daimelys Garcia, Dgarcia@entrustclinicalresearch.com
Adolfo Cueli
- Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Ilianys Marino, +1 786 502 4303, imarino@inpatientresearch.com
Alexis Gutierrez
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
Maya Patterson, +1 704 283 7359, Maya.Patterson@monroeresearch.com
Awawu Igbinadolor
- Recruiting
American Research Centers of FL
Pembroke Pines, Florida, 33027
Liliana Portal, lportal@americanresearchcenters.com
Luis Del Prado Rodriguez
- Recruiting
Sun Research Institute
San Antonio, Texas, 78205
Chandana Gagireddy, cgagireddy@sunresearch.com
Leonel Reyes
- Recruiting
Cen Exel FCR
Tampa, Florida, 33613
Kaylie Locascio, k.locascio@cenexel.com
Deborah White
- Recruiting
Oakland Medical Research Center
Troy, Michigan, 48085
Julie Lafave, +1 248 828 7500, jlafave@oaklandmedicalresearch.com
Jay Sandberg
- Recruiting
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Hiromi Hauserman, +1 561 537 4778, hiromi.hauserman@cardiologypartnerspl.com
Neerav Suresh Shah
- Recruiting
Alliance for Multispecialty Research
Wichita, Kansas, 67207
Layla Maxwell, layla.maxwell@amr-clinical.com
Jerry Punch
Japan4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031
- Recruiting
Novartis Investigative Site
Chuo-ku, Tokyo, 1030027
- Recruiting
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008
- Recruiting
Novartis Investigative Site
Suita, Osaka, 5650853
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 119074
- Recruiting
Novartis Investigative Site
Singapore, 529889
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension (HTN)
- Being tested
- QCZ484
- Keywords
- Hypertension, open-label extension study, QCZ484
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QCZ484Drug
QCZ484 subcutaneous injection, Q6M.
| Study group | Role | What they receive |
|---|---|---|
| QCZ484 | Experimental | QCZ484 administered subcutaneously (SC) Q6M Receives: Drug: QCZ484 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AEs
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Measured: Up to 66 months
Secondary outcomes (2)
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
Measured: 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
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)
Measured: Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start7 May 2026
- Primary completion31 May 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543120
- Sponsor's protocol ID
- CQCZ484A12203B
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT07543120
- Acronym / sponsor ID
- CQCZ484A12203B
- Conditions
- Hypertension (HTN)
- Keywords
- Hypertension, open-label extension study, QCZ484
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QCZ484 | Experimental | Drug: QCZ484QCZ484 administered subcutaneously (SC) Q6M |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QCZ484QCZ484 subcutaneous injection, Q6M. | Drug | QCZ484 |
Primary outcome
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
2 secondary outcomes
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 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: 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 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QCZ484 in people with Hypertension (HTN), run by Novartis Pharmaceuticals at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Japan, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with AEs (time frame: Up to 66 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.