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.

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En resumen

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.

Fase 2323 participantes buscados25 centros3 países

Categorías

Cardiovascular100%

Registrado en 1 registro

ClinicalTrials.govNCT07543120Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourEXPLORATORY

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

ScaleMEDIUM

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

Investigator standingUNKNOWN

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.

Resumen

This is a single arm, multicenter, OLE study designed to evaluate long-term safety, tolerability and efficacy of QCZ484, administered SC, once Q6M, in patients with HTN, who have successfully completed treatment period in the parent studies of the QCZ484 HTN program. Participants at sites from the parent study will be offered the option to enroll in this extension study at the Month 12 visit upon successful completion of the parent study treatment.

Afecciones

Hypertension (HTN)

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2
Asignación	No aplicable
Modelo de intervención	SINGLE_GROUP
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	323 participantes buscados

Patrocinador y colaboradores

Novartis Pharmaceuticals Patrocinador

Grupos e intervenciones

QCZ484EXPERIMENTAL
QCZ484 administered subcutaneously (SC) Q6M

Intervenciones

Fármaco QCZ484
QCZ484 subcutaneous injection, Q6M.

Variables de resultado

Variable de resultado principal
Number of participants with AEs
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Plazo Up to 66 months
Variable de resultado secundaria
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
Plazo Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
Variable de resultado secundaria
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)
Plazo Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Fechas

Fechas
Fecha de inicio	7 de mayo de 2026 (real)
Finalización principal	31 de mayo de 2031 (estimada)
Finalización	30 de noviembre de 2031 (estimada)
Primera publicación	21 de abril de 2026 (real)
Última actualización	30 de julio de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	julio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

25 centros están en reclutamiento

Japan

Japan
Centro	Ciudad	Estado o región	Estado
Novartis Investigative Site	Chuo Ku	Tokyo	En reclutamiento
Novartis Investigative Site	Chuo-ku	Tokyo	En reclutamiento
Novartis Investigative Site	Shinjuku Ku	Tokyo	En reclutamiento
Novartis Investigative Site	Suita	Osaka	En reclutamiento

Singapore

Singapore
Centro	Ciudad	Estado o región	Estado
Novartis Investigative Site	Singapore		En reclutamiento
Novartis Investigative Site	Singapore		En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
CenExel HRI	Berlin	New Jersey	En reclutamiento
Clinical Research of Brandon LLC	Brandon	Florida	En reclutamiento
Eagle Clinical Research	Chicago	Illinois	En reclutamiento
Conrad Clinical Research	Edmond	Oklahoma	En reclutamiento
Javara Research	Fayetteville	Georgia	En reclutamiento
Anderson Medical Research	Ft. Washington	Maryland	En reclutamiento
NICRs Research Center	Garden Grove	California	En reclutamiento
Jefferson City Medical Group	Jefferson City	Missouri	En reclutamiento
Downtown L A Research Center Inc	Los Angeles	California	En reclutamiento
Clinical Neuroscience Solutions Inc	Memphis	Tennessee	En reclutamiento
Entrust Clinical Research	Miami	Florida	En reclutamiento
Inpatient Research Clinical LLC	Miami Lakes	Florida	En reclutamiento
Monroe Biomedical Research	Monroe	North Carolina	En reclutamiento
American Research Centers of FL	Pembroke Pines	Florida	En reclutamiento
Sun Research Institute	San Antonio	Texas	En reclutamiento
Cen Exel FCR	Tampa	Florida	En reclutamiento
Oakland Medical Research Center	Troy	Michigan	En reclutamiento
Cardiology Partners Clinical Research Institute	Wellington	Florida	En reclutamiento
Alliance for Multispecialty Research	Wichita	Kansas	En reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

30 de julio de 2026
Centro añadido
12 sites added (25 total)
1325

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07543120