FindTrial
Sign In

Effects of three oral dosages of S 44121 on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A 3-day, single-blind, international multicentre study.

Effects of three oral dosages of S 44121 on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A 3-day, single-blind, international multicentre study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011560-11-FI
Enrollment
16
Registered
2009-11-24
Start date
2010-01-22
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Catecholaminergic polymorphic ventricular tachycardia (CPVT) type 1 MedDRA version: 12.0 Level: LLT Classification code 10036095 Term: Polymorphic ventricular tachycardia

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, age superior or equal to 18 years. - Established diagnosis of CPVT type 1. - Treatment with beta-blocker. - Qualifying ETs meeting a predefined degree of severity and stability of the disease. 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 F.1.3 Elderly (>=65 years) yes 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.—

Countries

Finland, France, Italy

Outcome results

None listed

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