Catecholaminergic Polymorphic Ventricular Tachycardia
Conditions
Brief summary
Safety: Incidence of AEs from receipt of the first dose of IMP and changes in standard safety assessments (which include physical examinations, vital signs, body weight, 12-lead ECG, and safety laboratory assessments), Tolerability (‘Tolerable Yes or No’): If any of following changes in IMP dosing is deemed necessary, the participant will be classified as ‘No’. • Dose adjustments prescribed by the Investigator • Dose interruptions prescribed by the Investigator • Discontinuation of treatment
Detailed description
Change from Baseline in the amount and complexity of exercise-induced ventricular ectopic beats as assessed using the ventricular arrythmia (VA) score at Day 1, Day 14, Day 27, Day 39, and Day 68., Change from Baseline in urine and plasma cGMP and cAMP levels at Day 1 (post-dose), Day 14, Day 27, Day 39, and Day 68.
Interventions
DRUGDNS-6288
Sponsors
Agiana Pharmaceuticals AS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of AEs from receipt of the first dose of IMP and changes in standard safety assessments (which include physical examinations, vital signs, body weight, 12-lead ECG, and safety laboratory assessments), Tolerability (‘Tolerable Yes or No’): If any of following changes in IMP dosing is deemed necessary, the participant will be classified as ‘No’. • Dose adjustments prescribed by the Investigator • Dose interruptions prescribed by the Investigator • Discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the amount and complexity of exercise-induced ventricular ectopic beats as assessed using the ventricular arrythmia (VA) score at Day 1, Day 14, Day 27, Day 39, and Day 68., Change from Baseline in urine and plasma cGMP and cAMP levels at Day 1 (post-dose), Day 14, Day 27, Day 39, and Day 68. | — |
Countries
Norway
Outcome results
None listed