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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2028-04-05

Brief Summary

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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

Detailed Description

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Phase 2b, multicenter, randomized, double-blind, placebo-controlled 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

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Hypertension

Keywords

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QCZ484 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo Control

Placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

0.9% sodium chloride saline solution

QCZ484 Dose 1

QCZ484 Dose 1 solution for injection

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

Solution of Injection

QCZ484 Dose 2

QCZ484 Dose 2 solution for injection

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

Solution of Injection

QCZ484 Dose 3

QCZ484 Dose 3 solution for injection

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

Solution of Injection

QCZ484 Dose 4

QCZ484 Dose 4 solution for injection

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

Solution of Injection

QCZ484 Dose 5

QCZ484 Dose 5 solution for injection

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

Solution of Injection

Interventions

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Saline

0.9% sodium chloride saline solution

Intervention Type OTHER

QCZ484

Solution of Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent.
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

1. Known history of secondary hypertension.
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SEC Clinical Research LLC

Andalusia, Alabama, United States

Site Status RECRUITING

UAB St Vincents

Birmingham, Alabama, United States

Site Status RECRUITING

Longwood Research

Huntsville, Alabama, United States

Site Status RECRUITING

The Center for Clinical Trials

Saraland, Alabama, United States

Site Status RECRUITING

Elite Clinical Studies

Phoenix, Arizona, United States

Site Status RECRUITING

Synexus Clinical Research US Inc

Tucson, Arizona, United States

Site Status RECRUITING

NICRs Research Center

Garden Grove, California, United States

Site Status RECRUITING

Valiance Clinical Research

Huntington Park, California, United States

Site Status RECRUITING

Downtown L.A. Research Center Inc

Los Angeles, California, United States

Site Status RECRUITING

Clinical Trials Research Sacramento

Sacramento, California, United States

Site Status RECRUITING

Encompass Clinical Research

Spring Valley, California, United States

Site Status RECRUITING

Clinical Research of Brandon LLC

Brandon, Florida, United States

Site Status RECRUITING

ALL Medical Research LLC

Cooper City, Florida, United States

Site Status RECRUITING

National Research Institute

Hialeah, Florida, United States

Site Status RECRUITING

Cen Exel RCA

Hollywood, Florida, United States

Site Status RECRUITING

East Coast Institute for Research

Jacksonville, Florida, United States

Site Status RECRUITING

Entrust Clinical Research

Miami, Florida, United States

Site Status RECRUITING

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Site Status RECRUITING

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status RECRUITING

Renstar Medical Research

Ocala, Florida, United States

Site Status RECRUITING

American Research Centers of FL

Pembroke Pines, Florida, United States

Site Status RECRUITING

Cen Exel FCR

Tampa, Florida, United States

Site Status RECRUITING

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Site Status RECRUITING

Centricity Research

Columbus, Georgia, United States

Site Status RECRUITING

Javara Research

Fayetteville, Georgia, United States

Site Status RECRUITING

Javara Research

Fayetteville, Georgia, United States

Site Status RECRUITING

Velocity Clinical Research

Savannah, Georgia, United States

Site Status RECRUITING

Solaris Clinical Research

Meridian, Idaho, United States

Site Status RECRUITING

Cedar Crosse Research Ct

Chicago, Illinois, United States

Site Status RECRUITING

Eagle Clinical Research

Chicago, Illinois, United States

Site Status RECRUITING

Synexus Clinical Research US

Evansville, Indiana, United States

Site Status RECRUITING

Velocity Clin Research Sioux City

Sioux City, Iowa, United States

Site Status RECRUITING

Alliance for Multispecialty Resrch

Wichita, Kansas, United States

Site Status RECRUITING

Velocity Clinical Res Baton Rouge

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Southern Clin Research Clinic

Zachary, Louisiana, United States

Site Status RECRUITING

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Site Status RECRUITING

Anderson Medical Research

Ft. Washington, Maryland, United States

Site Status RECRUITING

Capitol Cardiology Associates

Lanham, Maryland, United States

Site Status RECRUITING

AA Medical Research Center

Flint, Michigan, United States

Site Status RECRUITING

Oakland Medical Research Center

Troy, Michigan, United States

Site Status RECRUITING

Synexus Clinical Research US Inc

Richfield, Minnesota, United States

Site Status RECRUITING

David M Headley Clinic

Port Gibson, Mississippi, United States

Site Status RECRUITING

Healthcare Research Network II LLC

Hazelwood, Missouri, United States

Site Status RECRUITING

Jefferson City Medical Group

Jefferson City, Missouri, United States

Site Status RECRUITING

Clin Rsrch Consult a JCCT Company

Kansas City, Missouri, United States

Site Status RECRUITING

Velocity Clin at Pioneer Heart Inst

Lincoln, Nebraska, United States

Site Status RECRUITING

AMR Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

CenExel HRI

Berlin, New Jersey, United States

Site Status RECRUITING

Velocity Clinical Research

Binghamton, New York, United States

Site Status RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status RECRUITING

Burke Primary Care

Morganton, North Carolina, United States

Site Status RECRUITING

Accellacare of Rocky Mount

Rocky Mount, North Carolina, United States

Site Status RECRUITING

Accellacare of Salisbury

Salisbury, North Carolina, United States

Site Status RECRUITING

CR Services Acquisition US

Columbus, Ohio, United States

Site Status RECRUITING

Conrad Clinical Research

Edmond, Oklahoma, United States

Site Status RECRUITING

Velocity Clinical Research Medford

Medford, Oregon, United States

Site Status RECRUITING

TCV Clinical Studies

Linwood, Pennsylvania, United States

Site Status RECRUITING

Velocity Clinical Research

Union, South Carolina, United States

Site Status RECRUITING

Clinical Neuroscience Solutions Inc

Memphis, Tennessee, United States

Site Status RECRUITING

Velocity Clinical Research Austin

Austin, Texas, United States

Site Status RECRUITING

North Hills Medical Research Inc

Bedford, Texas, United States

Site Status RECRUITING

Synergy Group Medical LLC

Houston, Texas, United States

Site Status RECRUITING

Biopharma Informatic

Katy, Texas, United States

Site Status RECRUITING

Synergy Groups Medical LLC

Missouri City, Texas, United States

Site Status RECRUITING

Sun Research Institute

San Antonio, Texas, United States

Site Status RECRUITING

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status RECRUITING

AMR Layton

Layton, Utah, United States

Site Status RECRUITING

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status RECRUITING

Dominion Medical Associates

Richmond, Virginia, United States

Site Status RECRUITING

Centricity Research Suffolk Fam Med

Suffolk, Virginia, United States

Site Status RECRUITING

MultiCare Ins Research Innovation

Puyallup, Washington, United States

Site Status RECRUITING

Velocity Clinical Research Spokane

Spokane, Washington, United States

Site Status RECRUITING

Novartis Investigative Site

Suita, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Countries

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United States Japan Singapore

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

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