Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00887978
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Results First Submitted Date  ICMJE November 2, 2012
Results First Posted Date  ICMJE January 15, 2013
Last Update Posted Date January 15, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
Change in 6-minute walk distance from Baseline to Week 16
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Official Title  ICMJE 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
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • Drug: UT-15C SR
    treprostinil diolamine sustained release tablets
    Other Name: treprostinil diolamine, treprostinil diethanolamine, UT-15C
  • Drug: Placebo
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2012)
310
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Ireland,   Norway
 
Administrative Information
NCT Number  ICMJE NCT00887978
Other Study ID Numbers  ICMJE TDE-PH-308
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party United Therapeutics
Study Sponsor  ICMJE United Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lewis Rubin, MD University of California, San Diego
PRS Account United Therapeutics
Verification Date December 2012

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