Clinical Trials in Japan / NCT07543120
Recruiting
Phase 2
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
NCT07543120 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Hypertension (HTN)
Study 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.
Eligibility
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
Primary outcome measure(s)
- Number of participants with AEs — Up to 66 months
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| NICRs Research Center | Garden Grove | California | Recruiting |
| Downtown L A Research Center Inc | Los Angeles | California | Recruiting |
| Clinical Research of Brandon LLC | Brandon | Florida | Recruiting |
| Entrust Clinical Research | Miami | Florida | Recruiting |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | Recruiting |
| American Research Centers of FL | Pembroke Pines | Florida | Recruiting |
| Cen Exel FCR | Tampa | Florida | Recruiting |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | Recruiting |
| Javara Research | Fayetteville | Georgia | Recruiting |
| Eagle Clinical Research | Chicago | Illinois | Recruiting |
| Alliance for Multispecialty Research | Wichita | Kansas | Recruiting |
| Anderson Medical Research | Ft. Washington | Maryland | Recruiting |
| Oakland Medical Research Center | Troy | Michigan | Recruiting |
| Jefferson City Medical Group | Jefferson City | Missouri | Recruiting |
| CenExel HRI | Berlin | New Jersey | Recruiting |
| Monroe Biomedical Research | Monroe | North Carolina | Recruiting |
| Conrad Clinical Research | Edmond | Oklahoma | Recruiting |
| Clinical Neuroscience Solutions Inc | Memphis | Tennessee | Recruiting |
| Sun Research Institute | San Antonio | Texas | Recruiting |
| Novartis Investigative Site | Suita | Osaka | Recruiting |
| Novartis Investigative Site | Chuo Ku | Tokyo | Recruiting |
| Novartis Investigative Site | Chuo-ku | Tokyo | Recruiting |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | Recruiting |
| Novartis Investigative Site | Singapore | Singapore | Recruiting |
| Novartis Investigative Site | Singapore | Singapore | Recruiting |
More Novartis Pharmaceuticals trials in Japan
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07543120 on ClinicalTrials.gov ↗ ← All trials in Japan