Dettagli per singolo studio

DEC-NET Serial number ES574

Published online	25/04/2006 9.47.00
Last updated	02/05/2006 12.32.21

Other protocol ID number	AC-O52-405
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	PRIMARY PULMONARY HYPERTENSION
Experimental drug
Bosentan Treatment regimen (dosage and duration) Oral bosentan ·Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients ·Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Gender	Both
Age (range)	≥12 years
Eligibility criteria
Inclusion criteria
·Male or female patients ≥12 years with a body weight ≥40 kg(inclusive) and with a functional class III (1998 WHOclassification). ·Patients with pulmonary arterial hypertension related to Eisenmenger physiology echocardiographically established as atrial septal defect ≥2 cm effective diameter and/or ventricula rseptal defect ≥1 cm effective diameter; PAH confirmed viacardiac catheterization: mean pulmonary arterial pressure >25mm Hg, pulmonary capillary wedge pressure <15 mm Hg andpulmonary vascular resistance >3 mm Hg/l/min. ·Patients with documented oxygen saturation ≤90%, and >70%(at rest, with room air). ·Patients able to perform a 6-minute walk test ≥150 m, ≤450 m. ·Patients stable for at least 3 months prior to screening. ·Bosentan naļve patients. ·Female patients who are surgically sterile, postmenopausal or have documented infertility. ·Female patients of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g.,condom, diaphragm) used ONLY in combination with aspermicide. A double-barrier method is recommended;intrauterine devices (IUDs); oral or implanted contraceptives, ifused in combination with a barrier method. ·Patients providing written informed consent.
Exclusion criteria
·Pregnant patients, nursing mothers. ·Patients with left ventricular dysfunction (ejection fraction <40%). ·Patients with restrictive lung disease (TLC<70% predicted); obstructive lung disease (FEV1<70% predicted, with FEV1/FVC<60%) ·Patients with systolic blood pressure < 85 mm Hg. ·Patients with other conditions that may affect the ability to perform a 6-minute walk test. ·Patients unable to provide informed consent and comply with the patient protocol. ·Patients with known coronary arterial disease. ·Patients with serum creatinine >125 μM/l. ·Patients with iron deficiency (serum ferritin <10 ng/ml) unless corrected by iron supplement. ·Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted). ·Patients with AST and/or ALT values greater than 3 times the upper limit of normal. (others...)
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised Blinded Double blind
Purpose of study
Primary objective:To evaluate the effects of Tracleer on systemic oxygen saturationin patients with pulmonary arterial hypertension related to Eisenmenger physiology Secondary objectives:To evaluate the effects of Tracleer on: .Hemodynamics via cardiac catheterization .Exercise capacity via 6-minute walk test .Dyspnea .WHO functional class .Overall safety and tolerability
Primary outcomes
Change from baseline at week 16 in oxygen saturation at rest withroom air.
Secondary outcomes
·Changes from baseline at week 16 in 1.Cardiac hemodynamics 2.Cardiac Index 3.Mean pulmonary arterial pressure 4.Mean right arterial pressure 5.Pulmonary blood flow/systemic blood flow 6.Pulmonary vascular resistance/systemic vascular resistance 7.Systemic arterial oxygen saturation ·Exercise capacity as assessed by the 6-minute walk test ·Dyspnea as assessed by the Borg Dyspnea index ·WHO functional classification ·Proportion of patients with a decrease in oxygen saturation >10% from baseline to week 16