Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension (FREEDOM-Ev)

This study is currently recruiting participants.
Verified April 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560624
First received: March 9, 2012
Last updated: April 15, 2014
Last verified: April 2014

March 9, 2012
April 15, 2014
July 2012
May 2016   (final data collection date for primary outcome measure)
  • Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01560624 on ClinicalTrials.gov Archive Site
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Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension
A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects With Pulmonary Arterial Hypertension Receiving UT-15C in Combination With a PDE5-I or ERA Compared With a PDE5-I or ERA Alone

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving PDE-5 inhibitor or ERA for at least 30 days but not more than one year prior to randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: UT-15C (treprostinil diethanolamine)
    UT-15C sustained release oral tablets for three times daily administration
  • Drug: Placebo
    Placebo (sugar pill) for three times daily oral administration
  • Placebo Comparator: Placebo
    Matching placebo (sugar pill)
    Intervention: Drug: Placebo
  • Active Comparator: Active
    Active UT-15C Sustained release tablet
    Intervention: Drug: UT-15C (treprostinil diethanolamine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
858
August 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Between 18 and 75 years of age, inclusive
  2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use
  3. Receiving a PDE-5 inhibitor or ERA at an appropriate dose
  4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

  1. Nursing or pregnant
  2. PAH due to conditions other than noted in the above inclusion criteria
  3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease, uncontrolled systemic hypertension
  4. Use of an investigational drug or device within 30 days of Baseline
Both
18 Years to 75 Years
No
Not Provided
United States,   Australia,   Austria,   Canada,   China,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom
 
NCT01560624
TDE-PH-310
Yes
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP