Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertensio

Active, not recruiting

• Conditions: YHA Class III and IV patients with severe Pulmonary Arterial Hypertensio; MedDRA version: 14.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2004-003236-59-IT
• Lead Sponsor: nited Therapeutics Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Clinically stable male or famale patients of any racial origin with severe PAH (NYHA Class III or Class IV), 18 to 75 years of age, can do an un-encouraged 6 minute walk test of beetween 200 and 450 meters with following conditions. Previous cardiac cathetersation consist with PAH, specifically PAPm greater than or equal to 25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) less than or equal to 15 mmHG, and PVR major than 3 mmHG/L/min. Within the past 12 months patients must have had a chest radiograph consist with the diagnosis of PAH. Able to understand and willing to sign the ICF. HAve been on a stable course of 125mg of bosentan bid or stable dose of sildenafil for at lest 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pulmonary venous hypertension (PVOD), pulmonary capillary haemangiomatosis (PCH), severe COPD, congenital pulmonary hypertension or chronic thromboembolic pulmonary hypertension or any acute concomitant disease; congenital heart defect or congenital heart disease; pregnancy/lactation;change or discontinued any PAH medication within the last 3 months;received within the 30 days before trial or scheduled to receive any prostanoid, PDE5 inhibitors other than sildenafil or any investigational medicine;hemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified