Hypertension
Conditions
Interventions
Drug: QCZ484
QCZ484 subcutaneous injection, Q6M
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs up to 66 months | — |
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed