A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2009-009366-13-GB
• Date of registration: 07/08/2009
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics Corporation
• Public title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2
• Scientific title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2
• Date of first enrolment: 02/09/2009
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009366-13
• 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, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects are between 18 and 75 years of age, have a minimum weight of 40 kg and a Body Mass Index (BMI) <45kg/m2 , have a diagnosis of idiopathic or familial PAH, PAH associated with collagen vascular disease or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use or PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired >5 years) . The baseline 6-minute walk distance must be between 150 and 425 meters, inclusive. Subjects are receiving an approved ERA and/or an approved PDE-5 inhibitor for at least 90 days prior to randomization and are on a stable dose for 30 days.
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:
1)The subject is pregnant or lactating 2)The subject has received epoprostenol, treprostinil, iloprost, beraprost or any other prostacyclin therapy within 30 days of baseline (Except if used during acute vasoreactivity testing) 3)The subject has previously used UT-15C SR 4)The subject has had previous intolerance or significant lack of efficacy to an oral or parenteral prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy 5)The subject has any disease associated with PAH other than collagen vascular disease, HIV infection, or apetite suppressant/toxin use, or repaired congenital systemic-to-pulmonary shunts (repaired >5 years) (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease etc) or has had an atrial septostomy 6)The subject has a current diagnosis of uncontrolled sleep apnea as defined by their physician 7)The subject has chronic renal insufficiency as defined by either a Screening creatinine value greater than 2.5 mg/dL or the requirement for dialysis 8)The subject has liver function tests (AST or ALT) greater than three times the upper limit of normal at Screening 9)Has anemia as defined by a Screening hemoglobin value of less than 10g/dL, active infection, or any other condition that would interfere with the interpretation of study assessments 10)The subject has musculoskeletal disorder 11)The subject is receiving an investigational drug, has an investigation device in place or has participated in an investigational drug or device study within 30 days prior to screening


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

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension
MedDRA version: 14.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Product Name: treprostinil diethanolamine
Product Code: UT-15C
Pharmaceutical Form: Coated tablet
INN or Proposed INN: treprostinil diethanolamine
Current Sponsor code: UT-15C SR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.125-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 6-Minute Walk distance (6MWD) (i.e., distance traversed during the 6-Minute Walk Test)

Main Objective: To assess the effect of UT-15C SR on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.

Secondary Objective: To assess the effect of UT-15C SR on the following: 1)Clinical Worsening 2)Combined Walk Distance / Borg Dyspnea Score 3)N-terminal pro-Brain Natriuetic Peptide (BNP) 4)World Health Organization (WHO) Functional Class 5)Borg Dyspnea Score 6)Quality of Life (as measured by the CAMPHOR questionnaire where validated in the local language) 7)Dyspnea-Fatigue Index 8)Symptoms of PAH 9)Biomarkers (specific targets to be determined) 10)Safety (adverse events, clinical laboratory parameters, vital signs, electrocardiogram (ECG) findings)

Secondary ID(s)

TDE-PH-308