Clinical Trials in Italy / NCT06253221
Active, not recruiting
Phase 3
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
NCT06253221 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Cardiomyopathy, Hypertrophic
Investigational drug(s) / intervention(s)
Mavacamten →Placebo
Mavacamten: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Eligibility
Inclusion Criteria:
* Diagnosis of HCM
* Presence of LVOT obstruction
* Presence of symptoms
Exclusion Criteria:
* Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
* Evidence of LVEF \<50% in prior 6 months
* Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)
Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient — At Week 28
Trial sites (47)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0017 | Birmingham | Alabama | |
| Local Institution - 0050 | Phoenix | Arizona | |
| Local Institution - 0032 | Los Angeles | California | |
| Local Institution - 0008 | Los Angeles | California | |
| Local Institution - 0033 | Palo Alto | California | |
| Local Institution - 0044 | San Diego | California | |
| Local Institution - 0038 | Aurora | Colorado | |
| Local Institution - 0031 | St. Petersburg | Florida | |
| Local Institution - 0053 | Atlanta | Georgia | |
| Local Institution - 0013 | Chicago | Illinois | |
| Local Institution - 0009 | Indianapolis | Indiana | |
| Local Institution - 0043 | Boston | Massachusetts | |
| Local Institution - 0002 | Ann Arbor | Michigan | |
| Local Institution - 0037 | St Louis | Missouri | |
| Local Institution - 0052 | Morristown | New Jersey | |
| Local Institution - 0010 | New Hyde Park | New York | |
| Local Institution - 0024 | New York | New York | |
| Local Institution - 0036 | New York | New York | |
| Local Institution - 0040 | The Bronx | New York | |
| Local Institution - 0015 | Charlotte | North Carolina | |
| Local Institution - 0039 | Durham | North Carolina | |
| Local Institution - 0019 | Cincinnati | Ohio | |
| Local Institution - 0001 | Cleveland | Ohio | |
| Local Institution - 0029 | Columbus | Ohio | |
| Local Institution - 0030 | Philadelphia | Pennsylvania | |
| Local Institution - 0005 | Pittsburgh | Pennsylvania | |
| Local Institution - 0034 | Memphis | Tennessee | |
| Local Institution - 0045 | Austin | Texas | |
| Local Institution - 0054 | Houston | Texas | |
| Local Institution - 0003 | Salt Lake City | Utah | |
| Local Institution - 0012 | Charlottesville | Virginia | |
| Local Institution - 0020 | Sydney | New South Wales | |
| Local Institution - 0042 | Clayton | Victoria | |
| Local Institution - 0041 | Edmonton | Alberta | |
| Local Institution - 0046 | Toronto | Ontario | |
| Local Institution - 0022 | Paris | France | |
| Local Institution - 0026 | Pessac | France | |
| Local Institution - 0006 | Munich | Bavaria | |
| Local Institution - 0018 | Berlin | State of Berlin | |
| Local Institution - 0047 | Dublin 12, D12 N512 | Ireland |
+ 7 more sites — see the full list on the official registry below.
More Bristol-Myers Squibb trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06253221 on ClinicalTrials.gov ↗ ← All trials in Italy