Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2004-003236-59-AT
• Date of registration: 20/07/2005
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics Corporation
• Public title: Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
• Scientific title: Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
• Date of first enrolment: 24/08/2005
• 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

Countries of recruitment

Austria, Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Clinically stable male or female 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 between 200 and 450 meters with following conditions.
Previous cardiac catheterisation consistent 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 >3 mmHg/L/min. Within the past 12 months patients must have had a chest radiograph consistent with the diagnosis of PAH. Able to understand and willing to sign the Informed Consent Form.
Have been on a stable course of 125 mg of bosentan bid or a stable dose of sildenafil for at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
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; Cogenital heart defect or cogenital 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 medication; hemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids; new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, excepting anticoagulants; preexisting disease known to cause pulmonary hypertension (e.g., obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension); musculoskeletal disease or any other disease that would limit ambulation.


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 Hypertension (PAH)

Intervention(s)

Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: N/A
CAS Number: 81846-19-7
Current Sponsor code: Treprostinil solution for inhalation
Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.6-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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, and
(4) To assess the effect of TRE on troponin and Pro-BNP levels.

Main Objective: To determine the effects of chronically administered, inhaled Treprostinil Sodium (TRE) on exercise capacity with an un-encouraged 6-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 ten 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 ID(s)

2004-003236-59-GB

LRX–TRIUMPH-001