drugset / Trial / NCT04164732
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
Timeline
- Start
- 2020-01-08
- Primary completion
- 2023-08-22
- Completion
- 2023-08-22
Outcome
Missed primary endpoint
registry analysis (superiority test); LCZ696 BID vs Placebo BID; p = 0.5506; Median Difference (Net) 0.61 (80% CI -0.71 to 1.94); longitudinal mixed effects (MMRM) model NCT04164732 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacubitril | Small molecule | — | Oral |
| Subject | Valsartan | Unknown | — | Oral |
Indications
No indication recorded.