Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.
Conditions
Sponsors
Lilly ICOS LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -=12 years of age. -Body weight = 40 kg. -Currently have a diagnosis of PAH that is either: o idiopathic, o related to collagen vascular disease, o related to anorexigen use, o related to HIV infection o associated with an atrial septal defect (with resting arterial oxygen saturation = 88% on room air at screening), or o with surgical repair, of at least 1-year duration, of a congenital systemic-to-pulmonary shunt (e.g., 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, subjects with a left ventricular end diastolic pressure (LVEDP) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Are nursing or pregnant. -Have pulmonary hypertension related to conditions other than specified above, including but not limited to chronic thromboembolic disease, portal pulmonary hypertension, or left-sided heart disease. -For subjects with pulmonary arterial hypertension associated with an atrial septal defect, resting arterial oxygen saturation (SaO2) 160 mm Hg or 100 mm Hg or < 50 mm Hg at screening. -Have a history of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug. -Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease besides pulmonary hypertension that may significantly limit ambulation. -Have any new long-term treatment for pulmonary arterial hypertension added within 4 weeks before administration of study drug. -Have any therapy with a prostacyclin or analogue, L-arginine, phosphodiesterase inhibitor, or investigational drug within 4 weeks before administration of study drug. -Have any chronic PAH medication except for anticoagulants discontinued within 4 weeks prior to administration of study drug. -Current treatment with antiretroviral therapy (protease inhibitor), ketoconazole, or itraconazole. -Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. -Are employed by Lilly or ICOS (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or ICOS employees may participate in Lilly ICOS LLC-sponsored clinical trials, but are not permitted to participate at a Lilly or ICOS facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 6-minute walk distance change from baseline to Week 16.;Main Objective: To evaluate the safety and efficacy of the PDE5 inhibitor tadalafil in the treatment of patients with PAH.;Secondary Objective: To evaluate tadalafil population pharmacokinetics. | — |
Countries
Belgium, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed