JRCT ID: jRCT2031260200
Registered date:05/06/2026
An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension |
| Date of first enrollment | 16/06/2026 |
| Target sample size | 51 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Drug: QCZ484 QCZ484 subcutaneous injection, Q6M |
Outcome(s)
| Primary Outcome | Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs up to 66 months |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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. |
| Exclude 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. |
Related Information
| Primary Sponsor | Yamauchi Kyosuke |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT07543120 |
Contact
| Public contact | |
| Name | Kyosuke Yamauchi |
| Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
| Telephone | +81-120-003-293 |
| rinshoshiken.toroku@novartis.com | |
| Affiliation | Novartis Pharma. K.K. |
| Scientific contact | |
| Name | Kyosuke Yamauchi |
| Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
| Telephone | +81-120-003-293 |
| rinshoshiken.toroku@novartis.com | |
| Affiliation | Novartis Pharma. K.K. |