EUCTR2011-000579-15-DE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Catecholaminergic polymorphic ventricular tachycardia type 1
- Sponsor
- Institut de Recherches Internationales Servier
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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Completed
Phase 2
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 studycatecholaminergic polymorphic ventricular tachycardiainheritated heartrhythmdisorder10007521NL-OMON37671Servier R&D Benelux3