NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Hypertension (HTN)

Interventions: QCZ484

Countries: United States, Japan, Singapore

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (25)

Garden Grove, California, United States
Los Angeles, California, United States
Brandon, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Fayetteville, Georgia, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Ft. Washington, Maryland, United States
Troy, Michigan, United States
Jefferson City, Missouri, United States
Berlin, New Jersey, United States
Monroe, North Carolina, United States
Edmond, Oklahoma, United States
Memphis, Tennessee, United States
San Antonio, Texas, United States
Suita, Osaka, Japan
Chuo Ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Singapore, Singapore
Singapore, Singapore