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About
This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.
Enrollment
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Inclusion criteria
Exclusion criteria
Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
History of persistent atrial fibrillation prior to Screening or Baseline
History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
Systolic heart failure with ejection fraction <55% or heart failure symptoms of NYHA Class IV
QTcF >480 msec at Screening or Baseline
Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:
Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening
Primary purpose
Allocation
Interventional model
Masking
23 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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