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

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2004-003236-59-IT
• Date of registration: 09/11/2009
• Prospective Registration: No
• Primary sponsor: United Therapeutics Corporation
• Public title: Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension
• Scientific title: Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension
• Date of first enrolment: 30/05/2005
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003236-59
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

NYHA Class III and IV patients with severe Pulmonary Arterial Hypertensio
MedDRA version: 14.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: TRE
Pharmaceutical Form: Nebuliser liquid
INN or Proposed INN: Treprostinil Sodium Solution for Inhalation
Current Sponsor code: Treprostinil Sodium Solution for Inhalation
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 6-
Pharmaceutical form of the placebo: Nebuliser liquid
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: To determine the effects of chronically administered, inhaled Treprostinil Sodium (TRE) on exercise capacity with an unencouraged six-minute walk test (6MWT) in patients with pulmonary arterial hypertension (PAH).

Primary end point(s): Measure of efficacy will be improvement in exercise capacity as defined by the maximum distance a patient can walk in a peak unencouraged six minute walk test (6MWT) at 12 weeks when compared to baseline. A peak 6MWT is defined as a walk no less than 10 minutes and no more than 60 minutes post study drug inhalation. Additional analyses of the primary measure will be done on the 6MWT performed immediately following the first dose of study drug at Visit 2, and on the trough 6MWT results. A trough 6MWT is defined as a walk prior to or no less than 4 hours post study drug inhalation.

Secondary Objective: 1. To assess the safety and tolerability of chronically administered TRE 2. To assess the effects of chronically administered TRE on the signs and symptoms of PAH 3. To assess the effects of chronically administered TRE on NYHA Functional Class 4. To assess the effect of TRE on troponin and B-Type Natriuretic Peptide (BNP) levels.

Secondary ID(s)

LRX-TRIUMPH-001

2004-003236-59-GB