Status:
TERMINATED
Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Lead Sponsor:
Cardurion Pharmaceuticals, Inc.
Conditions:
CPVT1
Heart Defects, Congenital
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodyn...
Eligibility Criteria
Inclusion
- Males or Females ≥18 years of age, at screening.
- Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
- The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
- Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
- Adhere to all contraceptive criteria.
Exclusion
- Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
- History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
- Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
- Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06005428
Start Date
November 7 2023
End Date
May 31 2025
Last Update
July 14 2025
Active Locations (11)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States, 44195
3
Baylor College of Medicine
Houston, Texas, United States, 77030
4
Stollery Children's Hospital University of Alberta
Edmonton, Alberta, Canada, T6G 2R7