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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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 Teilnehmende gesucht25 Studienzentren3 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT07543120Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Zusammenfassung

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.

Erkrankungen

Hypertension (HTN)

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	323 Teilnehmende gesucht

Sponsor und Mitwirkende

Novartis Pharmaceuticals Sponsor

Studienarme und Interventionen

QCZ484EXPERIMENTAL
QCZ484 administered subcutaneously (SC) Q6M

Interventionen

Arzneimittel QCZ484
QCZ484 subcutaneous injection, Q6M.

Endpunkte

Primärer Endpunkt
Number of participants with AEs
Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs
Zeitrahmen Up to 66 months
Sekundärer Endpunkt
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
Zeitrahmen Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
Sekundärer Endpunkt
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)
Zeitrahmen Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Daten

Daten
Startdatum	7. Mai 2026 (tatsächlich)
Primärer Abschluss	31. Mai 2031 (geschätzt)
Abschluss	30. November 2031 (geschätzt)
Erstveröffentlichung	21. April 2026 (tatsächlich)
Zuletzt aktualisiert	30. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

25 Studienzentren rekrutieren

Japan

Japan
Einrichtung	Stadt	Bundesland oder Region	Status
Novartis Investigative Site	Chuo Ku	Tokyo	Rekrutiert
Novartis Investigative Site	Chuo-ku	Tokyo	Rekrutiert
Novartis Investigative Site	Shinjuku Ku	Tokyo	Rekrutiert
Novartis Investigative Site	Suita	Osaka	Rekrutiert

Singapore

Singapore
Einrichtung	Stadt	Bundesland oder Region	Status
Novartis Investigative Site	Singapore		Rekrutiert
Novartis Investigative Site	Singapore		Rekrutiert

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

30. Juli 2026
Studienzentrum hinzugefügt
12 sites added (25 total)
1325

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