An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
ConditionHypertension (HTN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
Qualifiers
Signed informed consent must be obtained prior to participation in the study.
Successful completion of treatment period on QCZ484 study medication in parent study.
No significant safety issue that may place participant at safety risk as determined by the Investigator.
Disqualifiers
Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.
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.
Permanent or persistent atrial fibrillation developed during the parent study.
Clinically significant valvular heart disease developed during the parent study.
Trial design
Treatments tested in this trial
- QCZ484
Treatment groups
323 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov