HypertensionPhase 2NCT06857955
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
A Phase 2 study testing Saline and QCZ484 in people with Hypertension, run by Novartis Pharmaceuticals at 72 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Saline and QCZ484
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 72 sitesin 3 countries
- Study dates
- 26 Mar 2025to 5 Apr 2028
- Phase
- Phase 2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Males or females aged 18 to 75 years.
- Diagnosis of hypertension.
- Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
- Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and <160 mmHg measured by ABPM.
- Participants able to understand and comply with study procedures.
Who cannot join
- Known history of secondary hypertension.
- Orthostatic hypotension.
- Laboratory parameter assessments outside of range at screening.
- Evidence of hepatic disease.
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- Any history of congestive heart failure.
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- Current or history of intolerance to ACEi and/or ARBs.
- Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
- Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
72 sites in 3 countries.
72 sites in 3 countries
United States63 sites
SEC Clinical Research LLC
Andalusia, Alabama, 36420
Velocity Clinical Research Austin
Austin, Texas, 78759
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
Velocity Clinical Res Baton Rouge
Baton Rouge, Louisiana, 70809
North Hills Medical Research Inc
Bedford, Texas, 76021
CenExel HRI
Berlin, New Jersey, 08009
Clinical Research of Brandon LLC
Brandon, Florida, 33511
Cedar Crosse Research Ct
Chicago, Illinois, 60607
Eagle Clinical Research
Chicago, Illinois, 60621
Centricity Research
Columbus, Georgia, 31904
CR Services Acquisition US
Columbus, Ohio, 43213
ALL Medical Research LLC
Cooper City, Florida, 33024
Conrad Clinical Research
Edmond, Oklahoma, 73013
Synexus Clinical Research US
Evansville, Indiana, 47714
Javara Research
Fayetteville, Georgia, 30214
AA Medical Research Center
Flint, Michigan, 48504
Anderson Medical Research
Ft. Washington, Maryland, 20744
NICRs Research Center
Garden Grove, California, 92844
Healthcare Research Network II LLC
Hazelwood, Missouri, 63042
National Research Institute
Hialeah, Florida, 33013
Cen Exel RCA
Hollywood, Florida, 33024
Synergy Group Medical LLC
Houston, Texas, 77061
Valiance Clinical Research
Huntington Park, California, 90255
Longwood Research
Huntsville, Alabama, 35801
East Coast Institute for Research
Jacksonville, Florida, 32216
Jefferson City Medical Group
Jefferson City, Missouri, 65109
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, 64112
Biopharma Informatic
Katy, Texas, 77479
Capitol Cardiology Associates
Lanham, Maryland, 20706
AMR Las Vegas
Las Vegas, Nevada, 89119
Velocity Clin at Pioneer Heart Inst
Lincoln, Nebraska, 68506
TCV Clinical Studies
Linwood, Pennsylvania, 19061
Downtown L A Research Center Inc
Los Angeles, California, 90017
Manassas Clinical Research Center
Manassas, Virginia, 20110
Velocity Clinical Research Medford
Medford, Oregon, 97504
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
Solaris Clinical Research
Meridian, Idaho, 83646
Entrust Clinical Research
Miami, Florida, 33176
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Synergy Groups Medical LLC
Missouri City, Texas, 77459
Monroe Biomedical Research
Monroe, North Carolina, 28112
Renstar Medical Research
Ocala, Florida, 34470
American Research Centers of FL
Pembroke Pines, Florida, 33027
Elite Clinical Studies
Phoenix, Arizona, 85018
Synexus Clinical Research US Inc
Richfield, Minnesota, 55432
Dominion Medical Associates
Richmond, Virginia, 23219
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804
Headlands Research Sacramento
Sacramento, California, 95821-2134
Accellacare of Salisbury
Salisbury, North Carolina, 28144
Sun Research Institute
San Antonio, Texas, 78205
Clinical Trials of Texas
San Antonio, Texas, 78229
The Center for Clinical Trials
Saraland, Alabama, 36571
Velocity Clinical Research
Savannah, Georgia, 31406
Velocity Clin Research Sioux City
Sioux City, Iowa, 51106
Encompass Clinical Research
Spring Valley, California, 91978-1522
Centricity Research Suffolk Fam Med
Suffolk, Virginia, 23435
Cen Exel FCR
Tampa, Florida, 33613
Oakland Medical Research Center
Troy, Michigan, 48085
Synexus Clinical Research US Inc
Tucson, Arizona, 85741
Velocity Clinical Research
Union, South Carolina, 29379
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Alliance for Multispecialty Research
Wichita, Kansas, 67207
Southern Clin Research Clinic
Zachary, Louisiana, 70791
Japan5 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 1030027
Novartis Investigative Site
Chuo Ku, Tokyo, 1040031
Novartis Investigative Site
Chuo-ku, Tokyo, 1030027
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1600008
Novartis Investigative Site
Suita, Osaka, 5650853
Singapore4 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 308433
Novartis Investigative Site
Singapore, 519466
Novartis Investigative Site
Singapore, 529889
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, 12 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of QCZ484 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
Read the detailed description
Phase 2b, multicenter, randomized, double-blind, placebo-controlled, 12 months treatment study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.
- Conditions
- Hypertension
- Being tested
- Saline, QCZ484
- Keywords
- QCZ484, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
0.9% sodium chloride saline solution
QCZ484Drug
Solution of Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Placebo Receives: Other: Saline |
| QCZ484 Dose 1 | Experimental | QCZ484 Dose 1 solution for injection Receives: Drug: QCZ484 |
| QCZ484 Dose 2 | Experimental | QCZ484 Dose 2 solution for injection Receives: Drug: QCZ484 |
| QCZ484 Dose 3 | Experimental | QCZ484 Dose 3 solution for injection Receives: Drug: QCZ484 |
| QCZ484 Dose 4 | Experimental | QCZ484 Dose 4 solution for injection Receives: Drug: QCZ484 |
| QCZ484 Dose 5 | Experimental | QCZ484 Dose 5 solution for injection Receives: Drug: QCZ484 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
Measured: Baseline, Month 3
Secondary outcomes (5)
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 6 in mean 24hr SBP by ABPM
Measured: Baseline, Month 6
Change in SBP by OBPM
Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Measured: Baseline, Month 3 and 6
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
Proportion of responders defined as participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Measured: Baseline, Month 3 and 6
Change in DBP by ABPM and OBPM
Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Measured: Baseline, Month 3 and 6
Number of participants with AEs
Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.
Measured: Up to Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start26 Mar 2025
- Primary completion17 Sep 2026
- Study completion5 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857955
- Sponsor's protocol ID
- CQCZ484A12201
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2025
- Last updated
- 23 Oct 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.