An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

Purpose

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.

Condition

  • Hypertension (HTN)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
QCZ484
QCZ484 administered subcutaneously (SC) Q6M
  • Drug: QCZ484
    QCZ484 subcutaneous injection, Q6M.

Recruiting Locations

NICRs Research Center
Garden Grove, California 92844
Contact:
Maria Murillo
+1 909 206 2454
mmurillo@nicresearch.com

Downtown L A Research Center Inc
Los Angeles, California 90017
Contact:
Claudia Cisneros
+1 213 261 3680
ccisneros@dtlaresearch.com

Entrust Clinical Research
Miami, Florida 33176
Contact:
Mariuchi Mayon
mmayon@entrustclinicalresearch.com

Inpatient Research Clinical LLC
Miami Lakes, Florida 33014
Contact:
Ilianys Marino
+1 786 502 4303
imarino@inpatientresearch.com

Cardiology Partners Clinical Research Institute
Wellington, Florida 33449
Contact:
Hiromi Hauserman
+1 561 537 4778
hiromi.hauserman@cardiologypartnerspl.com

Javara Research
Fayetteville, Georgia 30214
Contact:
Shemeka Williams
229 518 4947
swilliams@javararesearch.com

Anderson Medical Research
Ft. Washington, Maryland 20744
Contact:
Ann-Marie Cobb
andersonmedicalresearch@gmail.com

Jefferson City Medical Group
Jefferson City, Missouri 65109
Contact:
Suzin Cunningham
suzin.cunningham@avacare.com

Monroe Biomedical Research
Monroe, North Carolina 28112
Contact:
Maya Patterson
+1 704 283 7359
Maya.Patterson@monroeresearch.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

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.