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

• Conditions: Catecholaminergic polymorphic ventricular tachycardia type 1; MedDRA version: 14.1Level: LLTClassification code 10036095Term: Polymorphic ventricular tachycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000579-15-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-19
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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