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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.

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 recherchés25 sites3 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

  • Registered before enrolment beganFirst posted 2026-04-21; recorded start 2026-05-07
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
  • 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.

Résumé

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.

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.

Affections

  • Hypertension (HTN)

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2
RépartitionSans objet
Modèle d'interventionSINGLE_GROUP
Objectif principalTREATMENT
InsuNONE (0)
Recrutement323 participants recherchés

Promoteur et collaborateurs

  • Novartis Pharmaceuticals Promoteur

Groupes et interventions

  • QCZ484EXPERIMENTAL

    QCZ484 administered subcutaneously (SC) Q6M

Interventions

  • Médicament QCZ484

    QCZ484 subcutaneous injection, Q6M.

Critères de jugement

  1. Critère de jugement principal

    Number of participants with AEs

    Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs

    Délai Up to 66 months

  2. Critère de jugement secondaire

    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

    Délai Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)

  3. Critère de jugement secondaire

    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)

    Délai Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Dates

Date de début7 mai 2026 (réelle)
Achèvement principal31 mai 2031 (estimée)
Achèvement30 novembre 2031 (estimée)
Première publication21 avril 2026 (réelle)
Dernière mise à jour30 juillet 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

25 sites sont en recrutement

Japan

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteChuo KuTokyoEn recrutement
Novartis Investigative SiteChuo-kuTokyoEn recrutement
Novartis Investigative SiteShinjuku KuTokyoEn recrutement
Novartis Investigative SiteSuitaOsakaEn recrutement

Singapore

ÉtablissementVilleÉtat ou régionStatut
Novartis Investigative SiteSingaporeEn recrutement
Novartis Investigative SiteSingaporeEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
CenExel HRIBerlinNew JerseyEn recrutement
Clinical Research of Brandon LLCBrandonFloridaEn recrutement
Eagle Clinical ResearchChicagoIllinoisEn recrutement
Conrad Clinical ResearchEdmondOklahomaEn recrutement
Javara ResearchFayettevilleGeorgiaEn recrutement
Anderson Medical ResearchFt. WashingtonMarylandEn recrutement
NICRs Research CenterGarden GroveCaliforniaEn recrutement
Jefferson City Medical GroupJefferson CityMissouriEn recrutement
Downtown L A Research Center IncLos AngelesCaliforniaEn recrutement
Clinical Neuroscience Solutions IncMemphisTennesseeEn recrutement
Entrust Clinical ResearchMiamiFloridaEn recrutement
Inpatient Research Clinical LLCMiami LakesFloridaEn recrutement
Monroe Biomedical ResearchMonroeNorth CarolinaEn recrutement
American Research Centers of FLPembroke PinesFloridaEn recrutement
Sun Research InstituteSan AntonioTexasEn recrutement
Cen Exel FCRTampaFloridaEn recrutement
Oakland Medical Research CenterTroyMichiganEn recrutement
Cardiology Partners Clinical Research InstituteWellingtonFloridaEn recrutement
Alliance for Multispecialty ResearchWichitaKansasEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 30 juillet 2026

    Site ajouté

    12 sites added (25 total)

    1325

Registre: ClinicalTrials.gov · NCT########

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