A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
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
1 other identifier
interventional
385
3 countries
81
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hypertension
Started Mar 2025
Typical duration for phase_2 hypertension
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 5, 2028
June 1, 2026
May 1, 2026
1.8 years
March 3, 2025
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline, Month 3
Secondary Outcomes (5)
Change in Mean 24hr SBP by ABPM
Baseline, Month 6
Change in SBP by OBPM
Baseline, Month 3 and 6
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
Baseline, Month 3 and 6
Change in DBP by ABPM and OBPM
Baseline, Month 3 and 6
Number of participants with AEs
Up to Month 18
Study Arms (6)
Placebo Control
PLACEBO COMPARATORPlacebo
QCZ484 Dose 1
EXPERIMENTALQCZ484 Dose 1 solution for injection
QCZ484 Dose 2
EXPERIMENTALQCZ484 Dose 2 solution for injection
QCZ484 Dose 3
EXPERIMENTALQCZ484 Dose 3 solution for injection
QCZ484 Dose 4
EXPERIMENTALQCZ484 Dose 4 solution for injection
QCZ484 Dose 5
EXPERIMENTALQCZ484 Dose 5 solution for injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
SEC Clinical Research LLC
Andalusia, Alabama, 36420, United States
UAB St Vincents
Birmingham, Alabama, 35211, United States
Longwood Research
Huntsville, Alabama, 35801, United States
The Center for Clinical Trials
Saraland, Alabama, 36571, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Synexus Clinical Research US Inc
Tucson, Arizona, 85741, United States
NICRs Research Center
Garden Grove, California, 92844, United States
Valiance Clinical Research
Huntington Park, California, 90255, United States
Downtown L A Research Center Inc
Los Angeles, California, 90017, United States
Clinical Trials Research Sacramento
Sacramento, California, 95821-2134, United States
Encompass Clinical Research
Spring Valley, California, 91978-1522, United States
Clinical Research of Brandon LLC
Brandon, Florida, 33511, United States
ALL Medical Research LLC
Cooper City, Florida, 33024, United States
National Research Institute
Hialeah, Florida, 33013, United States
Cen Exel RCA
Hollywood, Florida, 33024, United States
East Coast Institute for Research
Jacksonville, Florida, 32216, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Suncoast Clinical Research
New Port Richey, Florida, 34452, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
American Research Centers of FL
Pembroke Pines, Florida, 33027, United States
Cen Exel FCR
Tampa, Florida, 33613, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
Centricity Research
Columbus, Georgia, 31904, United States
Javara Research
Fayetteville, Georgia, 30214, United States
Velocity Clinical Research
Savannah, Georgia, 31406, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Cedar Crosse Research Ct
Chicago, Illinois, 60607, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
Synexus Clinical Research US
Evansville, Indiana, 47714, United States
Velocity Clin Research Sioux City
Sioux City, Iowa, 51106, United States
Alliance for Multispecialty Research
Wichita, Kansas, 67207, United States
Velocity Clinical Res Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Southern Clin Research Clinic
Zachary, Louisiana, 70791, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197, United States
Synexus Clinical Research US Inc
Richfield, Minnesota, 55432, United States
Healthcare Research Network II LLC
Hazelwood, Missouri, 63042, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, 64111, United States
Velocity Clin at Pioneer Heart Inst
Lincoln, Nebraska, 68506, United States
AMR Las Vegas
Las Vegas, Nevada, 89119, United States
CenExel HRI
Berlin, New Jersey, 08009, United States
Velocity Clinical Research
Binghamton, New York, 13905, United States
Novant Health Heart Vas Inst
Charlotte, North Carolina, 28204, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804, United States
Accellacare of Salisbury
Salisbury, North Carolina, 28144, United States
CR Services Acquisition US
Columbus, Ohio, 43213, United States
Conrad Clinical Research
Edmond, Oklahoma, 73013, United States
Velocity Clinical Research Medford
Medford, Oregon, 97504, United States
TCV Clinical Studies
Linwood, Pennsylvania, 19061, United States
Velocity Clinical Research
Union, South Carolina, 29379, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119, United States
Velocity Clinical Research Austin
Austin, Texas, 78759, United States
North Hills Medical Research Inc
Bedford, Texas, 76021, United States
Synergy Group Medical LLC
Houston, Texas, 77061, United States
Biopharma Informatic
Katy, Texas, 77479, United States
Synergy Groups Medical LLC
Missouri City, Texas, 77459, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
AMR Layton
Layton, Utah, 84041, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
Centricity Research Suffolk Fam Med
Suffolk, Virginia, 23435, United States
MultiCare Ins Research Innovation
Puyallup, Washington, 98372, United States
Velocity Clinical Research Spokane
Spokane, Washington, 99218, United States
Novartis Investigative Site
Suita, Osaka, 5650853, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 103-0027, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 1030027, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008, Japan
Novartis Investigative Site
Singapore, 119074, Singapore
Novartis Investigative Site
Singapore, 308433, Singapore
Novartis Investigative Site
Singapore, 519466, Singapore
Novartis Investigative Site
Singapore, 529889, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 5, 2025
Study Start
March 26, 2025
Primary Completion (Estimated)
January 29, 2027
Study Completion (Estimated)
April 5, 2028
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is commited 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.