NCT07543120ClinicalTrials.gov
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.
In brief
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.
Phase 2323 participants sought25 sites3 countries
Categories
Registered in 1 registry
- ClinicalTrials.govNCT07543120Open this record at ClinicalTrials.govSynced 2 months ago
One study can be registered in several registries. We show it once and link every record we hold.
Trial information is shown as published by the registry, in its original language.
Interested in this study?
Sign in or create an account to register your interest and follow this study.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2026-04-21; recorded start 2026-05-07
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Allocation not stated in the record
- Blinding0/20
Open-label
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 13 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A medium-sized study, international in scope: 323 participants (target), run at 25 sites, across 3 countries.
How this score is built
- Enrolment24/40
323 participants (target)
- Site count13/25
13 sites
- Country count7/15
3 countries
- Planned duration10/10
Planned over about 68 months
- Sponsor scale10/10
Novartis Pharmaceuticals has led 1,104 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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.
Conditions
- Hypertension (HTN)
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Phase 2 |
| Allocation | Not applicable |
| Intervention model | SINGLE_GROUP |
| Primary purpose | TREATMENT |
| Masking | NONE (0) |
| Enrolment | 323 participants sought |
Sponsor and collaborators
- Novartis Pharmaceuticals Sponsor
Arms and interventions
- QCZ484EXPERIMENTAL
QCZ484 administered subcutaneously (SC) Q6M
Interventions
- Drug QCZ484
QCZ484 subcutaneous injection, Q6M.
Outcome measures
Primary outcome
Number of participants with AEs
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Time frame Up to 66 months
Secondary outcome
Change in SBP and DBP assessed by ambulatory blood pressure monitoring
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
Time frame Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
Secondary outcome
Change in SBP and DBP assessed by office blood pressure measurement
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)
Time frame Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)
Dates
| Start date | May 7, 2026 (actual) |
|---|---|
| Primary completion | May 31, 2031 (estimated) |
| Completion | November 30, 2031 (estimated) |
| First posted | April 21, 2026 (actual) |
| Last updated | July 30, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | July 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
25 sites are recruiting
Japan
| Facility | City | State or region | Status |
|---|---|---|---|
| Novartis Investigative Site | Chuo Ku | Tokyo | Recruiting |
| Novartis Investigative Site | Chuo-ku | Tokyo | Recruiting |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | Recruiting |
| Novartis Investigative Site | Suita | Osaka | Recruiting |
Singapore
| Facility | City | State or region | Status |
|---|---|---|---|
| Novartis Investigative Site | Singapore | Recruiting | |
| Novartis Investigative Site | Singapore | Recruiting |
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| CenExel HRI | Berlin | New Jersey | Recruiting |
| Clinical Research of Brandon LLC | Brandon | Florida | Recruiting |
| Eagle Clinical Research | Chicago | Illinois | Recruiting |
| Conrad Clinical Research | Edmond | Oklahoma | Recruiting |
| Javara Research | Fayetteville | Georgia | Recruiting |
| Anderson Medical Research | Ft. Washington | Maryland | Recruiting |
| NICRs Research Center | Garden Grove | California | Recruiting |
| Jefferson City Medical Group | Jefferson City | Missouri | Recruiting |
| Downtown L A Research Center Inc | Los Angeles | California | Recruiting |
| Clinical Neuroscience Solutions Inc | Memphis | Tennessee | Recruiting |
| Entrust Clinical Research | Miami | Florida | Recruiting |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | Recruiting |
| Monroe Biomedical Research | Monroe | North Carolina | Recruiting |
| American Research Centers of FL | Pembroke Pines | Florida | Recruiting |
| Sun Research Institute | San Antonio | Texas | Recruiting |
| Cen Exel FCR | Tampa | Florida | Recruiting |
| Oakland Medical Research Center | Troy | Michigan | Recruiting |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | Recruiting |
| Alliance for Multispecialty Research | Wichita | Kansas | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
- July 30, 2026
Site added
12 sites added (25 total)
1325