Clinical trial • Phase IV • Cardiology

landiolol hydrochloride for Cardiac arrest | Ventricular fibrillation

Phase IV trial of landiolol hydrochloride for Cardiac arrest | Ventricular fibrillation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Cardiac arrest | Ventricular fibrillation
Trial Stage
Phase IV
Drug Modality
Small molecule|Small molecule

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
10-12-2024

Trial design

Randomised, test: rapibloc (landiolol hydrochloride) - rapibloc 20 mg/2 ml concentrate for injection; route: intravenous bolus injection/iv infusion; max total dose 40 mg. comparator/placebo: sodium chloride injection/fresenius, 0.9% w/v; route: intravenous injection; max total dose 10 ml.-controlled Phase IV trial across 1 site in Austria.

Randomised
Yes
Comparator
Test: Rapibloc (landiolol hydrochloride) - Rapibloc 20 mg/2 ml concentrate for injection; route: INTRAVENOUS BOLUS INJECTION/IV INFUSION; max total dose 40 mg. Comparator/placebo: Sodium Chloride Injection/Fresenius, 0.9% w/v; route: INTRAVENOUS INJECTION; max total dose 10 ml.
Target Sample Size
48

Eligibility

Recruits 48 Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial population limited to adults (≥18). Subject information and informed consent form for adults available ('L1_SIS and ICF adults_redacted'). No assent procedures specified..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial population limited to adults (≥18). Subject information and informed consent form for adults available ('L1_SIS and ICF adults_redacted'). No assent procedures specified.

Inclusion criteria

  • {"criterion_text":"- OHCA , ³ 18 years of age\n- 3 or more shockable rhythms (VF or pVT) and last rhythm shockable"}

Exclusion criteria

  • {"criterion_text":"- Age > 85a\n- Severe head trauma or acute active bleeding\n- Known allergy or insensitivity to landiolol or another b-blocker"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time (in minutes) to sustained return of spontaneous circulation","definition_or_measurement_approach":"Time (in minutes) from infusion of study medication to sustained return of spontaneous circulation (sROSC) as stated in main objective."}

Secondary endpoints

  • {"endpoint_text":"- cummulative ROSC, temporary ROSC, sustained ROSC, survival at 24h, favorable neurologic outcome","definition_or_measurement_approach":"Not specified in the available CTIS record."}

Recruitment

Planned Sample Size
48
Recruitment Window Months
93
Consent Approach
Informed consent provided by adult participants. Subject information and ICF for adults available ('L1_SIS and ICF adults_redacted'). No assent for minors described. Languages of consent documents not specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
48

Austria

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
46
Number Of Sites
1
Number Of Participants
48

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Clinical Pharmacology
Contact Person Name
Michael Holzer

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Rapibloc 20 mg/2 ml Konzentrat zur Herstellung einer Injektionslösung
Active Substance
landiolol hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Marketing-authorised (marketingAuthNumber: 137586)
Maximum Dose
40 mg
Investigational Product Name
Sodium Chloride Injection/Fresenius, 0,9% w/v, διάλυμα για έγχυση
Active Substance
sodium chloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Authorisation Status
Marketing-authorised (marketingAuthNumber: 41233/09/12-02-2010)
Maximum Dose
10 ml

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