A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertensio

Phase 3

Completed

Conditions: high blood pressure in the small circulation
Pulmonal Arterial Hypertension
10037454

Registration Number: NL-OMON30667

Lead Sponsor: nited Therapeutics Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. The subject is between 12 and 70 years of age at Screening.
2. The subject weighs a minimum of 45 kg at Screening.
3. The subject, if female, is incapable of chilbearing of practicing an acceptable method of bith-control. For women of childbearing potential, a negative blood pregnancy test will be required at Screening.
4. The subject has a diagnosis of symptomatic Idiopathic or Familial PAH (including PAH associated with appetite suppressant/toxin use), PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired * 5 years), PAH associated with Collagen Vascular Disease, or PAH associated with HIV.
5. The subject, if HIV positive, has a CD4 lymphocyte count * 200 within 30 days of Baseline and is receiving current standard of casr anti-retroviral or other effective treatment for HIV.
6. The subject must have a Baseline 6-Minute Walk distance of between 150 and 450 meters inclusive.
7. The subject may benefit from the introduction of additional therapy (e.g. a prostacyclin) as determined by their medical provider.
8. The subject must have been optimally treated with approved oral therapies. Specifically, the subject:
a. Has been receiving approved PDE-5 inhibitor or approved ERA therapy alone for at least 90 days and at the current stable dose for 30 days prior to Baseline and is willing to remain on PDE-5 inhibitor or ERA alone and at the same dose for the duration of the 16-week Treatment Phase
or
b. Has been receiving the combination of approved PDE-5 inhibitor and approved ERA therapy for at least 90 days prior to Baseline with both treatments at the current stable dose at least 30 days prior to Baseline and is willing to remain on the combination of PDE-5 inhibitor and ERA at the same dose for the duration of the 16-week Treatment Phase.
9. The subject must be optimally treated with conventional pulmonary hypertension therapy
10. The subject voluntarily gives informed consent to participate in the study.

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.
3. The subject has had a new type of chronic therapy for pulmonary hypertension added within 30 days of Baseline.
4. The subject has had any PAH medication except for anticoagulants discontinued within 30 days of Baseline.
5. The subject has any disease associated with pulmonary arterial hypertension other than mentioned in the inclusion criteria.
6. The subject has a current diagnosis of uncontrolled sleep apnea.
7. The subject has chronic renal insufficiency.
8. The subject has anemia.
9. The subject has a history or current evidence of left-sided heart disease.
10. The subject has significant parenchymal lung disease.
11. The subject has uncontrolled systemic hypertension
12. The subject has any disease that is likely to limit ambulation.
13. The subject participates is another study or has participated in a study within 30 days prior to Screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the change in the distance traversed in the<br /><br>Six-Minute Walk Test at Week 16 over placebo in subjects with PAH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Borg Dyspnea Score<br /><br>Combined Walk and Borg Dyspnea Score<br /><br>Clinical Worsening<br /><br>Dyspnea-Fatigue Index<br /><br>WHO Functional Class<br /><br>Symptoms of PAH</p><br>