Phase 2
N=19
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01484431 ↗Enrolled (actual)
19
Serious AEs
42.1%
Results posted
Feb 2019
Primary outcome: Primary: Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil — 8170; 8390; 15200; 4550 nanograms* hour per milliliter(ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tadalafil- Tablet or Oral suspension (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil |
8170; 8390; 15200; 4550; 5000; 8990 | — |
| PRIMARY Population Pharmacokinetics: Average Concentration (Cmean,ss) of for Tadalafil at Steady-State. |
340; 350; 633; 190; 209; 375 | — |
| SECONDARY Percentage of Participants With Clinical Worsening |
50.00; 28.57; 33.33 | — |
| SECONDARY Number of Participants With Palatability of the Tadalafil Suspension |
0; 0; 0; 0; 3; 1 | — |
Summary
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
Eligibility Criteria
Inclusion Criteria
- Currently have a diagnosis of PAH that is either:
- idiopathic (including hereditary), related to collagen vascular disease, related to anorexigen use, associated with surgical repair, of at least 6 month duration, of a congenital systemic to pulmonary shunt (for example, atrial septal defect, ventricular septal defect, patent ductus arteriosus).
- Have a history of the diagnosis of PAH established by a resting mean pulmonary artery pressure ≥25 mm Hg, pulmonary artery wedge pressure ≤15 mm Hg, and a pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization. In the event that a pulmonary artery wedge pressure is unable to be obtained during right heart catheterization, participants with a left ventricular end diastolic pressure <15 mm Hg, with normal left heart function, and absence of mitral stenosis on echocardiography can be eligible for enrollment
- Have a World Health Organization (WHO) functional class value of I, II or III at the time of enrollment
Exclusion Criteria
- Have pulmonary hypertension related to conditions other than specified above, including but not limited to chronic thromboembolic disease, portal pulmonary hypertension, left-sided heart disease or lung disease and hypoxia
- History of left-sided heart disease, including any of the following:
- clinically significant (pulmonary artery occlusion pressure [PAOP] 15 to 18 mm Hg) aortic or mitral valve disease (that is, aortic stenosis, aortic insufficiency, mitral stenosis, moderate or greater mitral regurgitation)
- pericardial constriction
- restrictive or congestive cardiomyopathy
- left ventricular ejection fraction <40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
- left ventricular shortening fraction <22% by echocardiography
- life-threatening cardiac arrhythmias
- symptomatic coronary artery disease within 5 years of study entry as determined by the physician
- History of atrial septostomy or Potts Shunt within 3 months before administration of study drug
- Unrepaired congenital heart disease
Data sourced from ClinicalTrials.gov (NCT01484431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.