A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
NCT ID: NCT06857955
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
380 participants
INTERVENTIONAL
2025-03-26
2028-04-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Placebo Control
Placebo
Saline
0.9% sodium chloride saline solution
QCZ484 Dose 1
QCZ484 Dose 1 solution for injection
QCZ484
Solution of Injection
QCZ484 Dose 2
QCZ484 Dose 2 solution for injection
QCZ484
Solution of Injection
QCZ484 Dose 3
QCZ484 Dose 3 solution for injection
QCZ484
Solution of Injection
QCZ484 Dose 4
QCZ484 Dose 4 solution for injection
QCZ484
Solution of Injection
QCZ484 Dose 5
QCZ484 Dose 5 solution for injection
QCZ484
Solution of Injection
Interventions
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Saline
0.9% sodium chloride saline solution
QCZ484
Solution of Injection
Eligibility Criteria
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Inclusion Criteria
2. Males or females aged 18 to 75 years.
3. Diagnosis of hypertension.
4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM.
6. Participants able to understand and comply with study procedures.
Exclusion Criteria
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening.
4. Evidence of hepatic disease.
5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
6. Any history of congestive heart failure.
7. Current or history of intolerance to ACEi and/or ARBs.
8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
9. 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.
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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SEC Clinical Research LLC
Andalusia, Alabama, United States
UAB St Vincents
Birmingham, Alabama, United States
Longwood Research
Huntsville, Alabama, United States
The Center for Clinical Trials
Saraland, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Synexus Clinical Research US Inc
Tucson, Arizona, United States
NICRs Research Center
Garden Grove, California, United States
Valiance Clinical Research
Huntington Park, California, United States
Downtown L.A. Research Center Inc
Los Angeles, California, United States
Clinical Trials Research Sacramento
Sacramento, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Clinical Research of Brandon LLC
Brandon, Florida, United States
ALL Medical Research LLC
Cooper City, Florida, United States
National Research Institute
Hialeah, Florida, United States
Cen Exel RCA
Hollywood, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
American Research Centers of FL
Pembroke Pines, Florida, United States
Cen Exel FCR
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Centricity Research
Columbus, Georgia, United States
Javara Research
Fayetteville, Georgia, United States
Javara Research
Fayetteville, Georgia, United States
Velocity Clinical Research
Savannah, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cedar Crosse Research Ct
Chicago, Illinois, United States
Eagle Clinical Research
Chicago, Illinois, United States
Synexus Clinical Research US
Evansville, Indiana, United States
Velocity Clin Research Sioux City
Sioux City, Iowa, United States
Alliance for Multispecialty Resrch
Wichita, Kansas, United States
Velocity Clinical Res Baton Rouge
Baton Rouge, Louisiana, United States
Southern Clin Research Clinic
Zachary, Louisiana, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Capitol Cardiology Associates
Lanham, Maryland, United States
AA Medical Research Center
Flint, Michigan, United States
Oakland Medical Research Center
Troy, Michigan, United States
Synexus Clinical Research US Inc
Richfield, Minnesota, United States
David M Headley Clinic
Port Gibson, Mississippi, United States
Healthcare Research Network II LLC
Hazelwood, Missouri, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, United States
Velocity Clin at Pioneer Heart Inst
Lincoln, Nebraska, United States
AMR Las Vegas
Las Vegas, Nevada, United States
CenExel HRI
Berlin, New Jersey, United States
Velocity Clinical Research
Binghamton, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States
Accellacare of Salisbury
Salisbury, North Carolina, United States
CR Services Acquisition US
Columbus, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
Velocity Clinical Research Medford
Medford, Oregon, United States
TCV Clinical Studies
Linwood, Pennsylvania, United States
Velocity Clinical Research
Union, South Carolina, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, United States
Velocity Clinical Research Austin
Austin, Texas, United States
North Hills Medical Research Inc
Bedford, Texas, United States
Synergy Group Medical LLC
Houston, Texas, United States
Biopharma Informatic
Katy, Texas, United States
Synergy Groups Medical LLC
Missouri City, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
AMR Layton
Layton, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Dominion Medical Associates
Richmond, Virginia, United States
Centricity Research Suffolk Fam Med
Suffolk, Virginia, United States
MultiCare Ins Research Innovation
Puyallup, Washington, United States
Velocity Clinical Research Spokane
Spokane, Washington, United States
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Lauren Williams
Role: primary
Ashley Gilmore
Role: primary
Jeff Dunlap
Role: primary
JoAnn Ladner
Role: primary
Evette San-Miguel
Role: primary
Heather Hickey
Role: primary
Maria Murillo
Role: primary
Josh Lai
Role: primary
Claudia Cisneros
Role: primary
Leesa Koskela
Role: primary
Klarissa Felix
Role: primary
Maylin Barrios
Role: primary
Alejandro Marin
Role: primary
Leonor Balbuena
Role: primary
Katherine Garcia
Role: primary
Katie Graf
Role: primary
Pablo Columbie
Role: primary
Sergio Ramirez
Role: primary
Ana Laura Lopez
Role: primary
Felicia Shonte Jones
Role: primary
Stephanie Latino
Role: primary
Liz Perez
Role: primary
Kaylie Locascio
Role: primary
Hiromi Hauserman
Role: primary
Tatum Blandin
Role: primary
Kiara McFarland Head
Role: primary
Shemeka Williams
Role: primary
Mayra Del Real
Role: primary
Tricia Simon
Role: primary
Kareem Aburas
Role: primary
Denniqua Scott
Role: primary
Melody Werne
Role: primary
Emily Stewart
Role: primary
Shaunacie McCallum
Role: primary
Calah Williams
Role: primary
Brandi Kenney
Role: primary
Morgan Beatty
Role: primary
Ann-Marie Cobb
Role: primary
Iluyomade Adeusi
Role: primary
Fayyaz Shah
Role: primary
Julie Lafave
Role: primary
Kaila Schacker
Role: primary
Deborah Spencer
Role: primary
Cyndi Puckett
Role: primary
Hunter Mistler
Role: primary
Hasan Mahdi
Role: primary
Ohildamis Martin
Role: primary
Michael Yee
Role: primary
Tammara Dixon
Role: primary
Asia Carpenter
Role: primary
Lindsay Piccolo
Role: primary
Jeneen Radford
Role: primary
Jessica Clanin
Role: primary
Anna Rollans
Role: primary
Sowjanya Polumatla
Role: primary
Shelly Todd
Role: primary
Levi Gadbois
Role: primary
Jessica Bryant
Role: primary
Franziska Crowe
Role: primary
Irene Powell
Role: primary
Jeremiah Fortenberry
Role: primary
Hector Ochoa
Role: primary
Reina Romero
Role: primary
Minhah Mushtaq
Role: primary
Graciela Lopez
Role: primary
Beneta Parthiban
Role: primary
Andrea Zepeda
Role: primary
Abby Robbins
Role: primary
Vanesa Romero
Role: primary
Claretha Nelson
Role: primary
Shavon Cooke
Role: primary
Fawna White
Role: primary
Alicia Sullivan
Role: primary
Other Identifiers
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CQCZ484A12201
Identifier Type: -
Identifier Source: org_study_id