RightFit
RecruitingPhase 2

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

A Multicenter Open-label Extension Study to Evaluate Long-term Safety and Efficacy of QCZ484 in Hypertensive Patients.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This follow-up study checks the safety of QCZ484 and how well it works over more time. It is for people with high blood pressure who successfully finished treatment in an earlier QCZ484 study allowed by the study plan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study before taking part.
  • Successfully finish the QCZ484 treatment period in the earlier study.
  • Have no major safety problem that the study doctor thinks could put you at risk.

Who can't join

  • Have liver disease that the study doctor thinks would make long-term QCZ484 use unsafe.
  • Develop a serious heart rhythm problem or a severe block in the heart's electrical signals during the earlier study. Some blocks exclude you only if you have no pacemaker.
  • Develop lasting atrial fibrillation, a type of irregular heartbeat, during the earlier study.
  • Develop serious heart valve disease during the earlier study.
  • Have a heart attack or unstable angina (new or worsening chest pain) during the earlier study.
  • Have a procedure to open blocked heart arteries or heart bypass surgery during the earlier study.
  • Have ever had a stroke or a transient ischemic attack (a mini-stroke) before joining this study.
  • Other rules in the study plan may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (19)

CA

FL

GA

IL

KS

MD

MI

MO

NC

NJ

OK

TN

TX