Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

Phase 2

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Parenteral Remodulin (treprostinil) injection; Drug: Oral Treprostinil

• Registration Number: NCT03016468
• Lead Sponsor: United Therapeutics

Brief Summary

This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11
• Study Start: 2017-05
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease, PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or PAH associated with appetite suppressant or toxin use.
2. The subject must be classified as WHO FC II or III at Baseline.
3. The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.
4. Subject is in need of escalation of therapy, as determined by the Investigator.
5. Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC stimulator and/or an ERA and has been at the current stable dose for at least 28 days prior to Baseline.

Exclusion Criteria

1. The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.

2. The subject has a Baseline 6MWD of less than 150 meters.

3. The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.

4. The subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of Baseline), or a history of left sided myocardial dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection fraction less than 40%.

5. The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.

6. The subject has a history of 1 or more of the following signs of relevant lung disease within 180 days before Baseline:

   1. Total lung capacity less than 60% of predicted normal.
   2. Forced expiratory volume in 1 second is less than 55% of predicted normal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parenteral Remodulin then Oral Treprostinil	Parenteral Remodulin (treprostinil) injection	-
Parenteral Remodulin then Oral Treprostinil	Oral Treprostinil	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) through 16 Weeks	16 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16	Baseline and Week 16
Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16	Baseline and Week 16
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16	Baseline and Week 16
Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16	Baseline and Week 16
Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16	Baseline and Week 16