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.
Phase 1
- Conditions
- Catecholaminergic polymorphic ventricular tachycardia (CPVT) type 1MedDRA version: 12.0Level: LLTClassification code 10036095Term: Polymorphic ventricular tachycardia
- Registration Number
- EUCTR2009-011560-11-FR
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
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
- 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.
- Secondary Outcome Measures
Name Time Method