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Effects of acute and chronic oral administration of S44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1

Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-000579-15-FI
Enrollment
Unknown
Registered
2011-10-31
Start date
2012-02-01
Completion date
Unknown
Last updated
2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catecholaminergic polymorphic ventricular tachycardia type 1 MedDRA version: 14.1 Level: LLT Classification code 10036095 Term: Polymorphic ventricular tachycardia System Organ Class: 100000004849

Interventions

Product Name: S44121 Product Code: S44121 Pharmaceutical Form: Granules for oral suspension Current Sponsor code: S44121 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female patients aged 18 years or more - Established diagnosis of CPVT type 1 - Treatment with beta-blocker - Qualifying ETs meeting a predefined degree of severity and stability of the disease - Presence of an ICD for primary or secondary prevention of ventricular arrhythmia implanted at least 3 months prior to pre-selection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Resting ECG with an abnormality that could preclude a proper interpretation of the ECG obtained during the ETs - Chronic heart failure - Structural congenital heart disease

Design outcomes

Primary

MeasureTime frame
Main Objective: - Evaluation of the effects on the occurence of cardiac arrhythmia during standardized exercise tests (ETs);Secondary Objective: - Evaluation of the safety profile;Primary end point(s): Cardiac arrhythmias during standardised ETs;Timepoint(s) of evaluation of this end point: All over the study—

Secondary

MeasureTime frame
Secondary end point(s): - Clinical safety measurements (12-lead resting ECG, 24-hour Holter recording, adverse events, blood pressure and blood clinical laboratory parameters);Timepoint(s) of evaluation of this end point: All over the study—

Countries

Brazil, Finland, France, Germany, Hungary, Italy, Netherlands, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026