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Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension (FREEDOM-C2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887978
First Posted: April 24, 2009
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
April 23, 2009
April 24, 2009
November 2, 2012
January 15, 2013
January 15, 2013
June 2009
July 2011   (Final data collection date for primary outcome measure)
6-minute Walk Distance (6MWD) [ Time Frame: Baseline and 16 weeks ]

Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).

The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).

Change in 6-minute walk distance from Baseline to Week 16
Complete list of historical versions of study NCT00887978 on ClinicalTrials.gov Archive Site
  • Clinical Worsening Assessment [ Time Frame: Baseline and 16 Weeks ]

    Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study:

    1. Death (all causes excluding accident)
    2. Transplantation
    3. Atrial septostomy
    4. Hospitalization as a result of right heart failure
    5. Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i
    6. Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH
  • Borg Dyspnea Score [ Time Frame: Baseline and 16 Weeks ]
    The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).
  • World Health Organization (WHO) Functional Class [ Time Frame: Baseline and 16 Weeks ]
    Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
  • Symptoms of PAH [ Time Frame: Baseline and 16 Weeks ]
    Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.
  • Dyspnea Fatigue Index [ Time Frame: Baseline and 16 Weeks ]
    The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.
  • N-terminal proBNP (NT-proBNP) [ Time Frame: Baseline and 16 Weeks ]
    Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.
  • Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [ Time Frame: Baseline and 16 Weeks ]
    Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.
  • Borg Dyspnea Score
  • Clinical Worsening Assessment
  • Dyspnea Fatigue Index
  • Symptoms of PAH
  • World Health Organization (WHO) Functional Class
  • Clinical laboratory parameters
  • Electrocardiogram findings
  • Adverse Events
  • N-terminal pro-BNP
  • Vital Signs
  • Biomarkers
  • Combined ranking of distance walked and Borg Dyspnea Score from the 6-Minute Walk Test
  • Quality of Life
Not Provided
Not Provided
 
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
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

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: UT-15C SR
    treprostinil diolamine sustained release tablets
    Other Name: treprostinil diolamine, treprostinil diethanolamine, UT-15C
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Identical placebo tablets to UT-15C, doses were titrated in the same manner
    Intervention: Drug: Placebo
  • Experimental: UT-15C SR
    Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
    Intervention: Drug: UT-15C SR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A subject is eligible for inclusion in this study if all of the following criteria apply:
  • Between 18 and 75 years of age, inclusive.
  • Body weight at least 40 kg (approximately 90 lbs.)
  • PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.
  • Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
  • Baseline six-minute walk distance (6MWD) between 150-425 meters
  • Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
  • Reliable and cooperative with protocol requirements.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Ireland,   Norway
 
NCT00887978
TDE-PH-308
Yes
Not Provided
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Study Chair: Lewis Rubin, MD University of California, San Diego
United Therapeutics
December 2012

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