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CRD-4730 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT Trial)
Phase 2
Recruiting
Research Sponsored by Cardurion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 22
Summary
This trial studies the safety, PK & PD of CRD-4730 to treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) in 2 cohorts of participants receiving single doses.
Who is the study for?
Adults over 18 with confirmed CPVT, a heart condition causing irregular rapid heartbeats, can join. They must be able to do an exercise test and have been on stable doses of anti-arrhythmic meds (except amiodarone) for 4 weeks. Participants need to follow strict birth control rules.
What is being tested?
The trial tests CRD-4730's safety and effects in people with CPVT compared to a placebo. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo during the study.
What are the potential side effects?
Specific side effects aren't listed but generally may include issues related to how well CRD-4730 is tolerated by patients' bodies and its interaction with their current medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CPVT through genetic testing and clinical assessment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 22
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 22
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Electrocardiogram (ECG) Measurements
Changes in Laboratory Assessments
Changes in Physical Exam
+5 moreSecondary study objectives
Assessment of PK effect
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment1 Intervention
CRD-4730 Dose 2 capsule
Group II: Dose 1Experimental Treatment1 Intervention
CRD-4730 Dose 1 capsule
Group III: Dose 3Placebo Group1 Intervention
Placebo capsule to match CRD-4730
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Who is running the clinical trial?
Cardurion Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
732 Total Patients Enrolled
Jason Homsy, M.D., Ph.D.Study DirectorExecutive Medical Director
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