A Phase 2 interventional study of Ifetroban and Placebo in Duchenne Muscular Dystrophy Cardiomyopathy and Cardiomyopathy, Dilated, sponsored by Cumberland Pharmaceuticals. Completed at 10 sites in United States. Open to male participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Cumberland Pharmaceuticals · Phase 2, Interventional, and Treatment
Duchenne muscular dystrophy (DMD) is a devastating X-linked disease which leads to loss of ambulation between ages 7 and 13, respiratory failure and cardiomyopathy (CM) at any age, and inevitably premature death of affected young men in their late twenties. DMD is the most common fatal genetic disorder diagnosed in childhood. It affects approximately 1 in every 3,500 live male births across all races and cultures, and results in 20,000 new cases each year worldwide.Significant advances in respiratory care have unmasked CM as the leading cause of death. As there are yet no specific cardiac treatments to extend life, the current study aims to address this unmet medical need using a new therapeutic strategy for patients with DMD.
Funding Source - FDA OOPD
This is a phase 2 randomized, double-blind, placebo-controlled, multiple dose study with an optional open-label extension to determine the safety, pharmacokinetics (PK) and efficacy of two doses of oral ifetroban in subjects with DMD. DMD patients who meet the inclusion criteria and none of the exclusion criteria will receive oral ifetroban or placebo once daily for 12 months. Subjects will be enrolled into one of three treatment groups, low-dose ifetroban, high-dose ifetroban or placebo. Each dose level will be evaluated by eight subjects with early stage (LVEF > 45%) DMD-associated cardiomyopathy and eight subjects with more advanced stage (LVEF 35-45%) cardiac disease as there may be differences in the treatment effect based on cardiac involvement. Each subject treated will be evaluated for first-dose and steady-state exposure PK. All subjects who receive treatment will be assessed for safety. All subjects with at least one efficacy assessment post-baseline will be evaluated for efficacy. Blood and urine will be collected for standard and novel cardiac biomarkers. Target enrollment met for early-stage subjects (LVEF > 45%); study closed to enrollment prior to meeting target enrollment in the late-stage cohort (LVEF 35-45%). All subjects who complete the 12-month study are eligible to enter an optional open label extension period consisting of treatment with high-dose ifetroban only. Subjects in the open label extension will be evaluated for safety and cardiac efficacy every 12 months.
255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.
This study's enrollment of 46 is close to the median of 43 across 145 interventional studies indexed under Cardiomyopathy, Dilated.
Browse Cardiomyopathy, Dilated studies →Cumberland Pharmaceuticals is the lead sponsor of 49 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable cardiac function defined as change in (LVEF) of \< 15% and no heart failure admission over the last 12 months; LVEF 35% or greater by cine cardiac magnetic resonance imaging (MRI) or echocardiography; myocardial damage in one or more left ventricular segments evident by late gadolinium enhancement allowed; concurrent angiotensin-converting enzyme inhibitors (ACEI), beta-blocker (BB) or angiotensin receptor blocker (ARB) therapy allowed (selection of which dictated by clinical care) if started three months or greater from first dose of IMP without change in dose. Aldosterone receptor antagonists (eg. Spironolactone or eplerenone) allowed if started 12 months or greater from first dose of Medicinal Product (IMP). No changes throughout the study allowed, except in the event of a decline in left ventricular ejection fraction (LVEF) >5% following the baseline CMR as measured by a subsequent CMR at the same center. Should this occur, changes in cardiac medications are allowed on the study.
a. Late-stage cohort: Subjects are eligible for the late-stage cohort if the subject has: i. LVEF 35%-45% by cine cardiac magnetic resonance imaging (MRI) or echocardiography or ii. historically documented LVEF 35%-45% by cine cardiac magnetic resonance imaging (MRI) or echocardiography and if their baseline MRI is less than 50%.
Exclusion criteria:
Allergy to gadolinium contrast or known renal insufficiency defined as abnormal cystatin C or creatinine above the for age. The male serum reference ranges as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight based, once daily oral ifetroban
Drug: Ifetroban
Weight based, once daily oral ifetroban
Drug: Ifetroban
Matching Placebo
Drug: Placebo
Weight based, once daily oral ifetroban
Matching oral placebo
Incidence of Treatment-Emergent Adverse Events
Percentage of subjects with one or more treatment emergent adverse event
Time frame: Baseline through 12 months
Pharmacokinetics Area Under the Curve
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. Area under the curve until the last measurement was calculated for the plasma concentration versus time curves for ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
Time frame: Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post-dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7
Pharmacokinetics Maximum Serum Concentration (Cmax)
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the maximum plasma concentration of ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
Time frame: Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7
Pharmacokinetics Time to Reach Cmax (Tmax) Concentration
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the time to maximum plasma concentration of ifetroban and its acyl glucuronide metabolite following administration of assigned oral ifetroban dose
Time frame: Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7
Pharmacokinetics Plasma Terminal Half-life Concentration
Plasma ifetroban were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. The terminal elimination half-life was calculated from the plasma concentration versus time curves for ifetroban following administration of assigned oral ifetroban dose
Time frame: Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7
Change From Baseline in Left Ventricular Ejection Fraction
Change from baseline at month 12 in left ventricular ejection fraction
Time frame: Baseline visit and Month 12 visit
Change From Baseline in FEV1
Change from baseline at month 12 in Forced Expiratory Volume in 1 second
Time frame: Baseline through month 12
Change From Baseline in Percent Predicted FEV1
Change from baseline at month 12 in percent predicted Forced Expiratory Volume in 1 second
Time frame: Baseline through month 12
Change From Baseline in FVC
Change from baseline at month 12 in Forced Vital Capacity
Time frame: Baseline through month 12
Change From Baseline in Percent Predicted FVC
Change from baseline at month 12 in percent predicted Forced Vital Capacity
Time frame: Baseline through month 12
Change From Baseline in Maximal Expiratory Pressure
Change from baseline at month 12 in maximal expiratory pressure
Time frame: Baseline through month 12
Change From Baseline in Maximal Inspiratory Pressure
Change from baseline at month 12 in maximal inspiratory pressure
Time frame: Baseline through month 12
Change From Baseline in Peak Expiratory Flow Rate
Change from baseline at month 12 in peak expiratory flow rate
Time frame: Baseline through month 12
Change From Baseline in Percent Predicted Peak Expiratory Flow Rate
Change from baseline at month 12 in percent predicted peak expiratory flow rate
Time frame: Baseline through month 12
Change From Baseline in Quality-of-life
The Pediatric Quality of Life Inventory (PedQL) questionnaire measures core dimensions of health as delineated by the World Health Organization. The core module includes 23 items comprising 14 dimensions. The Gastrointestinal module includes 74 items comprising 14 dimensions. The Neuromuscular module includes 25 items comprising 3 dimensions. Each item in the modules is measured on a 5-point Likert scale of 0-4 with 0 indicating 'never' and 4 indicating 'almost always'. The Likert scores for each subscale are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life. Subscale scores are averaged to generate the total score reported with a range of 0-100. Results are presented as change from baseline at 12 months. The questionnaire was completed by the participant and the parent/guardian of the participant.
Time frame: Baseline through 12 months
Patients were randomized 1:1:1 to receive either high dose ifetroban, low dose ifetroban, or matching placebo daily for 52 weeks.
| Milestone | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Started | 18 | 12 | 11 |
| Completed | 13 | 9 | 8 |
| Not completed | 5 | 3 | 3 |
| Withdrew: Adverse event | 3 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Milestone | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Started | 13 | 9 | 8 |
| Completed | 10 | 7 | 8 |
| Not completed | 3 | 2 | 0 |
Percentage of subjects with one or more treatment emergent adverse event
| Participants | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Any TEAE | 14 | 9 | 10 |
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. Area under the curve until the last measurement was calculated for the plasma concentration versus time curves for ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
| h*ng/mL | High Dose Ifetroban | Low Dose Ifetroban |
|---|---|---|
| Ifetroban | 3196 ± 2485 | 761 ± 585 |
| Ifetroban Glucuronide | 45116 ± 30211 | 13789 ± 9700 |
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the maximum plasma concentration of ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
| ng/mL | High Dose Ifetroban | Low Dose Ifetroban |
|---|---|---|
| Ifetroban | 1560 ± 2028 | 272 ± 300 |
| Ifetroban Glucuronide | 9787 ± 7148 | 2276 ± 1955 |
Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the time to maximum plasma concentration of ifetroban and its acyl glucuronide metabolite following administration of assigned oral ifetroban dose
| h | High Dose Ifetroban | Low Dose Ifetroban |
|---|---|---|
| Ifetroban | 0.71 ± 0.24 | 1.09 ± 1.2 |
| Ifetroban Glucuronide | 2.81 ± 6.43 | 1.89 ± 2.47 |
Plasma ifetroban were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. The terminal elimination half-life was calculated from the plasma concentration versus time curves for ifetroban following administration of assigned oral ifetroban dose
| h | High Dose Ifetroban | Low Dose Ifetroban |
|---|---|---|
| Pharmacokinetics Plasma Terminal Half-life Concentration | 12.96 ± 5.73 | 8.99 ± 4.6 |
Change from baseline at month 12 in left ventricular ejection fraction
| Percentage of LVEF | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction | 1.8 ± 5.44 | 0 ± 5.16 | -1.5 ± 3.27 |
Change from baseline at month 12 in Forced Expiratory Volume in 1 second
| Liters | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in FEV1 | -0.05 ± 0.233 | -0.11 ± 0.294 | 0.01 ± 0.169 |
Change from baseline at month 12 in percent predicted Forced Expiratory Volume in 1 second
| Percent | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Percent Predicted FEV1 | -1.92 ± 10.67 | -7.89 ± 9.226 | -3.29 ± 6.775 |
Change from baseline at month 12 in Forced Vital Capacity
| Liters | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in FVC | -0.08 ± 0.291 | -0.07 ± 0.378 | -0.08 ± 0.291 |
Change from baseline at month 12 in percent predicted Forced Vital Capacity
| Percent | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Percent Predicted FVC | -3.31 ± 10.491 | -6.11 ± 11.050 | -8.14 ± 15.700 |
Change from baseline at month 12 in maximal expiratory pressure
| cm of water | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Maximal Expiratory Pressure | -1.69 ± 8.625 | 2.00 ± 16.466 | -16.50 ± 25.774 |
Change from baseline at month 12 in maximal inspiratory pressure
| cm of water | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Maximal Inspiratory Pressure | -6.00 ± 7.000 | -9.13 ± 8.935 | 1.17 ± 20.14 |
Change from baseline at month 12 in peak expiratory flow rate
| Liters/second | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Peak Expiratory Flow Rate | 0.09 ± 0.643 | -0.19 ± 0.414 | 0.51 ± 0.844 |
Change from baseline at month 12 in percent predicted peak expiratory flow rate
| Percent | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Change From Baseline in Percent Predicted Peak Expiratory Flow Rate | -3.58 ± 15.395 | -3.83 ± 11.250 | 2.40 ± 20.477 |
The Pediatric Quality of Life Inventory (PedQL) questionnaire measures core dimensions of health as delineated by the World Health Organization. The core module includes 23 items comprising 14 dimensions. The Gastrointestinal module includes 74 items comprising 14 dimensions. The Neuromuscular module includes 25 items comprising 3 dimensions. Each item in the modules is measured on a 5-point Likert scale of 0-4 with 0 indicating 'never' and 4 indicating 'almost always'. The Likert scores for each subscale are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 5=25, and 4=0. A higher score indicates better health-related quality of life. Subscale scores are averaged to generate the total score reported with a range of 0-100. Results are presented as change from baseline at 12 months. The questionnaire was completed by the participant and the parent/guardian of the participant.
| Scores on a scale | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| Generic Core Module (Participant Response) | -0.06 ± 15.9 | 4.39 ± 11.5 | -4.03 ± 13.1 |
| Generic Core Module (Parent Response) | -7.62 ± 14.3 | 0.43 ± 19.6 | -11.4 ± 21.5 |
| Gastrointestinal Module (Participant Response) | -7.08 ± 22.7 | 4.08 ± 6.45 | -2.03 ± 10.7 |
| Gastrointestinal Module (Parent Response) | 4.20 ± 6.59 | -0.03 ± 7.62 | -5.57 ± 4.95 |
| Neuromuscular Module (Participant Response) | 1.31 ± 10.4 | 3.49 ± 13.0 | 1.93 ± 12.0 |
| Neuromuscular Module (Parent Response) | 7.77 ± 8.01 | 2.00 ± 6.74 | -6.57 ± 10.3 |
Collected over From initiation of treatment through study completion, up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose Ifetroban | 0/18 (0%) | 3/18 (16.7%) | 14/18 (77.8%) |
| Low Dose Ifetroban | 0/12 (0%) | 2/12 (16.7%) | 9/12 (75%) |
| Placebo | 0/11 (0%) | 2/11 (18.2%) | 10/11 (90.9%) |
| Event | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| PneumoniaInfections and infestations | 2/18 | 1/12 | 0/11 |
| Femur fractureInjury, poisoning and procedural complications | 0/18 | 0/12 | 1/11 |
| FallInjury, poisoning and procedural complications | 0/18 | 0/12 | 1/11 |
| Hip fractureInjury, poisoning and procedural complications | 0/18 | 0/12 | 1/11 |
| Cerebrovascular accidentNervous system disorders | 0/18 | 1/12 | 0/11 |
| Oesophageal obstructionGastrointestinal disorders | 0/18 | 1/12 | 0/11 |
| HypervolaemiaMetabolism and nutrition disorders | 0/18 | 1/12 | 0/11 |
| DehydrationMetabolism and nutrition disorders | 1/18 | 0/12 | 0/11 |
| Metabolic acidosisMetabolism and nutrition disorders | 1/18 | 0/12 | 0/11 |
| Event | High Dose Ifetroban | Low Dose Ifetroban | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 2/18 | 2/12 | 3/11 |
| HeadacheNervous system disorders | 2/18 | 1/12 | 3/11 |
| COVID-19Infections and infestations | 4/18 | 1/12 | 2/11 |
| VomitingGastrointestinal disorders | 3/18 | 1/12 | 2/11 |
| Abdominal painGastrointestinal disorders | 0/18 | 0/12 | 2/11 |
| NasopharyngitisInfections and infestations | 2/18 | 1/12 | 2/11 |
| Back painMusculoskeletal and connective tissue disorders | 1/18 | 0/12 | 2/11 |
| Delayed pubertyEndocrine disorders | 0/18 | 0/12 | 2/11 |
| DiarrhoeaGastrointestinal disorders | 2/18 | 1/12 | 1/11 |
| PneumoniaInfections and infestations | 2/18 | 1/12 | 0/11 |
| Age, Continuous(Years) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Mean | 18.2 ± 5.9 | 17.3 ± 5.8 | 14.7 ± 4.9 | 17.0 ± 5.7 |
| Sex: Female, Male(Participants) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 18 | 12 | 11 | 41 |
| Race (NIH/OMB)(Participants) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 16 | 12 | 10 | 38 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 3 | 4 |
| Not Hispanic or Latino | 17 | 12 | 8 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Weight(kg) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Mean | 54.3 ± 17.9 | 53.2 ± 20.7 | 42.4 ± 16.9 | 50.8 ± 18.8 |
| BMI (kg/m^2)(Participants) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| < 18.5 (Underweight) | 3 | 0 | 3 | 6 |
| 18.5 - 24.9 (Normal weight) | 7 | 7 | 5 | 19 |
| 25.0 - 29.9 (Overweight) | 5 | 3 | 1 | 9 |
| ≥ 30 (Obese) | 3 | 2 | 2 | 7 |
| BMI Z-scores(Z-score) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Mean | 0.62 ± 1.4 | 1.1 ± 0.71 | 0.15 ± 2.2 | 0.59 ± 1.6 |
| Ambulatory(Participants) | High Dose Ifetroban | Low Dose Ifetroban | Placebo | Total |
|---|---|---|---|---|
| Yes | 8 | 4 | 4 | 16 |
| No | 10 | 8 | 7 | 25 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2020 to primary completion in Mar 2024, 40 months.
Results were first posted in Jan 2026, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ifetroban