Study Description
The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols. This is a single arm, multicenter, OLE study designed to evaluate long-term safety, tolerability and efficacy of QCZ484, administered SC, once Q6M, in patients with HTN, who have successfully completed treatment period in the parent studies of the QCZ484 HTN program.
Participants at sites from the parent study will be offered the option to enroll in this extension study at the Month 12 visit upon successful completion of the parent study treatment.
Interventions
QCZ484
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation in the study.
2. Successful completion of treatment period on QCZ484 study medication in parent study.
3. No significant safety issue that may place participant at safety risk as determined by the Investigator.
Exclusion Criteria:
Participants meeting any of the following criteria, may it be pre-existing or developed during the parent study, are not eligible for inclusion in this study:
1. Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade atrioventricular (AV) block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) developed during the parent study.
3. Permanent or persistent atrial fibrillation developed during the parent study.
4. Clinically significant valvular heart disease developed during the parent study.
5. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) developed during the parent study. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to enrollment.
Other protocol-defined inclusion/exclusion criteria may apply
Novartis Investigative Site
Recruiting
Chuo-ku,Tokyo,1030027,Japan
Novartis Investigative Site
Recruiting
Chuo Ku,Tokyo,104-0031,Japan
Novartis Investigative Site
Recruiting
Shinjuku Ku,Tokyo,160-0008,Japan
Novartis Investigative Site
Recruiting
Suita,Osaka,5650853,Japan
Novartis Investigative Site
Recruiting
Singapore,529889,Singapore
Novartis Investigative Site
Recruiting
Singapore,119074,Singapore
Alliance for Multispecialty Research
Recruiting
Wichita,Kansas,67207,United States
Jerry Punch
Layla Maxwell
American Research Centers of FL
Recruiting
Pembroke Pines,Florida,33027,United States
Luis Del Prado Rodriguez
Liliana Portal
Cen Exel FCR
Recruiting
Tampa,Florida,33613,United States
Deborah White
Kaylie Locascio
Sun Research Institute
Recruiting
San Antonio,Texas,78205,United States
Leonel Reyes
Chandana Gagireddy
Clinical Neuroscience Solutions Inc
Recruiting
Memphis,Tennessee,38119,United States
Lora J. McGill
Eagle Clinical Research
Recruiting
Chicago,Illinois,60621,United States
Iesha Griffin
Olalekan Sowade
Oakland Medical Research Center
Recruiting
Troy,Michigan,48085,United States
Jay Sandberg
Clinical Research of Brandon LLC
Recruiting
Brandon,Florida,33511,United States
Erika Santos
German Alvarez
CenExel HRI
Recruiting
Berlin,New Jersey,08009,United States
Kyle Coupe
Conrad Clinical Research
Recruiting
Edmond,Oklahoma,73013,United States
Shelly Todd
Vicki Conrad
Monroe Biomedical Research
Recruiting
Monroe,North Carolina,28112,United States
Awawu Igbinadolor
NICRs Research Center
Recruiting
Garden Grove,California,92844,United States
Mallu Reddy
Entrust Clinical Research
Recruiting
Miami,Florida,33176,United States
Adolfo Cueli
Daimelys Garcia
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,Florida,33014,United States
Alexis Gutierrez
Javara Research
Recruiting
Fayetteville,Georgia,30214,United States
William Cooper
Anderson Medical Research
Recruiting
Ft. Washington,Maryland,20744,United States
Ann-Marie Cobb
Felton Anderson
Downtown L A Research Center Inc
Recruiting
Los Angeles,California,90017,United States
Salil U Nadkarni
Cardiology Partners Clinical Research Institute
Recruiting
Wellington,Florida,33449,United States
Neerav Suresh Shah
Jefferson City Medical Group
Recruiting
Jefferson City,Missouri,65109,United States
George Carr
Suzin Cunningham
Worldwide Contacts
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