Hypertension (HTN)
Conditions
Keywords
Hypertension, open-label extension study, QCZ484
Brief summary
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.
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.
Interventions
DRUGQCZ484
QCZ484 subcutaneous injection, Q6M.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | Up to 66 months | Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SBP and DBP assessed by ambulatory blood pressure monitoring | Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study) | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline (parent study) and from Day 1 of the OLE and at Months 12 and so on (every 12 months) assessed by assessed by ambulatory blood pressure monitoring (ABPM) - applicable only for the subgroup of participants who had ABPM in the parent study |
| Change in SBP and DBP assessed by office blood pressure measurement | Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study) | Change in SBP and DBP from Baseline (parent study) and from Day 1 of the OLE and at Months 6, 12 and so on (Q6M) assessed by assessed by office blood pressure measurement (OBPM) |
Countries
Japan, Singapore, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed