Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy, Obstructive Cardiomyopathy
Conditions
Brief summary
Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).
Detailed description
Proportion of patients at Week 26 with a New York Heart Association (NYHA) functional class improvement ≥ 1 category, Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS), Treatment-emergent adverse events (TEAEs) reported during the double-blind treatment period and through Week 30., Clinical laboratory results (including serum creatinine and estimated glomerular filtration rate [eGFR]) and vital signs through Week 26., Change from Baseline at Week 4 and Week 26 in left ventricular outflow tract (LVOT) gradient (at rest and with Valsalva maneuver) as measured by echocardiogram.
Interventions
DRUGPLACEBO SOTAGLIFLOZIN
DRUGSOTAGLIFLOZIN
Sponsors
Lexicon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients at Week 26 with a New York Heart Association (NYHA) functional class improvement ≥ 1 category, Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS), Treatment-emergent adverse events (TEAEs) reported during the double-blind treatment period and through Week 30., Clinical laboratory results (including serum creatinine and estimated glomerular filtration rate [eGFR]) and vital signs through Week 26., Change from Baseline at Week 4 and Week 26 in left ventricular outflow tract (LVOT) gradient (at rest and with Valsalva maneuver) as measured by echocardiogram. | — |
Countries
Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden
Outcome results
None listed