Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

Browse trials for

• Hypertension, Pulmonary 1,105
• Pulmonary Arterial Hypertension 761
• Hypertension 6,689

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 310 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Lead sponsor

United Therapeutics is the lead sponsor of 81 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.

Eligibility criteria

Study arms

• Placebo comparator
  Placebo

  Identical placebo tablets to UT-15C, doses were titrated in the same manner

  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.

  Drug: UT-15C SR

Interventions

• DrugUT-15C SR

  treprostinil diolamine sustained release tablets

  Also known as: treprostinil diolamine, treprostinil diethanolamine, UT-15C

• DrugPlacebo

Primary outcomes

1. 6-minute Walk Distance (6MWD)

   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).

   Time frame: Baseline and 16 weeks

Secondary outcomes

1. Clinical Worsening Assessment

   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

   Time frame: Baseline and 16 Weeks

2. Borg Dyspnea Score

   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).

   Time frame: Baseline and 16 Weeks

3. World Health Organization (WHO) Functional Class

   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.

   Time frame: Baseline and 16 Weeks

4. Symptoms of PAH

   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.

   Time frame: Baseline and 16 Weeks

5. Dyspnea Fatigue Index

   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.

   Time frame: Baseline and 16 Weeks

6. N-terminal proBNP (NT-proBNP)

   Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.

   Time frame: Baseline and 16 Weeks

7. Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)

   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.

   Time frame: Baseline and 16 Weeks

Baseline characteristics

Publications

• Richter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671. PubMed 28090293 ↗
• Tapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875. PubMed 23669822 ↗