Study Description
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 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.
Interventions
QCZ484
Saline
Eligibility Criteria
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.
Other protocol-defined inclusion/exclusion criteria may apply
Novartis Investigative Site
Recruiting
Shinjuku ku,Tokyo,160-0008,Japan
Novartis Investigative Site
Recruiting
Suita,Osaka,565-0853,Japan
Novartis Investigative Site
Recruiting
Chuo-ku,Tokyo,103-0027,Japan
Novartis Investigative Site
Recruiting
Chuo ku,Tokyo,104-0031,Japan
Novartis Investigative Site
Recruiting
Singapore,519466,Singapore
Novartis Investigative Site
Recruiting
Singapore,308433,Singapore
Novartis Investigative Site
Recruiting
Singapore,119074,Singapore
Novartis Investigative Site
Recruiting
Singapore,529889,Singapore
Healthcare Research Network II LLC
Recruiting
Hazelwood,Missouri,63042,United States
Lyndsay Goeke
Larry Reed
Monroe Biomedical Research
Recruiting
Monroe,North Carolina,28112,United States
Awawu Igbinadolor
ALL Medical Research LLC
Recruiting
Cooper City,Florida,33024,United States
Catherine Cruz
Craig Shapiro
Lorena Lewy-Alterbaum
Centricity Research
Recruiting
Columbus,Georgia,31904,United States
Zulfiquar Bhatti
Danesha Bankhead
Javara Research
Recruiting
Fayetteville,Georgia,30214,United States
William Cooper
Frank N Cole
Encompass Clinical Research
Recruiting
Spring Valley,California,91978-1522,United States
Hanid Audish
Aracely Ramos
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
Downtown L.A. Research Center Inc
Recruiting
Los Angeles,California,90017,United States
Salil Nadkarni
Synergy Groups Medical LLC
Recruiting
Missouri City,Texas,77459,United States
Deirdre McMullen
American Research Centers of FL
Recruiting
Pembroke Pines,Florida,33027,United States
Luis Del Prado Rodriguez
Liliana Portal
SEC Clinical Research LLC
Recruiting
Andalusia,Alabama,36420,United States
Donavon Wewers
Dominion Medical Associates
Recruiting
Richmond,Virginia,23219,United States
Richard A Jackson
Eagle Clinical Research
Recruiting
Chicago,Illinois,60621,United States
Olalekan Sowade
Iesha Griffin
Jefferson City Medical Group
Recruiting
Jefferson City,Missouri,65109,United States
George Carr
Suzin Cunningham
Clinical Neuroscience Solutions Inc
Recruiting
Memphis,Tennessee,38119,United States
Lora J. McGill
Suncoast Clinical Research
Recruiting
New Port Richey,Florida,34452,United States
Cathy Barnes
Sophia Falciani
Sun Research Institute
Recruiting
San Antonio,Texas,78205,United States
Leonel Reyes
Melissa Martinez
Cen Exel FCR
Recruiting
Tampa,Florida,33613,United States
Deborah White
Frances Encarnacion
Centricity Research Suffolk Fam Med
Recruiting
Suffolk,Virginia,23434,United States
Samir Abdelshaheed
Synexus Clinical Research US
Recruiting
Evansville,Indiana,47714,United States
Abriah Abdul-Wali
Mohammed Allaw
Burke Primary Care
Recruiting
Morganton,North Carolina,28655,United States
Stephen Keith Smith
Tara Tilson
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Solaris Clinical Research
Recruiting
Meridian,Idaho,83646,United States
David Butuk
Clinical Trials Research Sacramento
Recruiting
Sacramento,California,95821-2134,United States
Jeffrey D Wayne
Oakland Medical Research Center
Recruiting
Troy,Michigan,48085,United States
Jay Sandberg
Synexus Clinical Research US Inc
Recruiting
Tucson,Arizona,85741,United States
Judith Brown
CenExel HRI
Recruiting
Berlin,New Jersey,08009,United States
Michael Hassman
Alliance for Multispecialty Resrch
Recruiting
Wichita,Kansas,67207,United States
Jerry Punch
Josiah Cubol
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Jean Foucauld
East Coast Institute for Research
Recruiting
Jacksonville,Florida,32223,United States
James Sample Magee
Manassas Clinical Research Center
Recruiting
Manassas,Virginia,20110,United States
Laura Reyes
Nabil Andrawis
Ascension Saint Agnes Heart Care
Recruiting
Baltimore,Maryland,21229,United States
Jeffrey Cole
Entrust Clinical Research
Recruiting
Miami,Florida,33176,United States
Adolfo Cueli
Lynda Velazquez
North Hills Medical Research Inc
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
Cedar Crosse Research Ct
Recruiting
Chicago,Illinois,60607,United States
Danny Hiroshi Sugimoto
Clinical Research of Brandon LLC
Recruiting
Brandon,Florida,33511,United States
German Alvarez
Yarisel Alvarez
Synexus Clinical Research US Inc
Recruiting
Richfield,Minnesota,55432,United States
Kaila Schacker
Melissa Choi
NICRs Research Center
Recruiting
Garden Grove,California,92844,United States
Jesus David Lopez-Merino
Mallu Reddy
Conrad Clinical Research
Recruiting
Edmond,Oklahoma,73013,United States
Vicki Conrad
Willow Gravitt
Anderson Medical Research
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.