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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03016468
• Other study ID #: TDE-PH-207
• Status: Withdrawn
• Phase: Phase 2
• First received: January 6, 2017
• Last updated: April 7, 2017
• Start date: May 2017
• Est. completion date: September 2018

Study information

• Verified date: April 2017
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Parenteral Remodulin (treprostinil) injection
Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
• Oral Treprostinil
Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) through 16 Weeks		16 Weeks
Secondary	Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16		Baseline and Week 16
Secondary	Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16		Baseline and Week 16
Secondary	Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16		Baseline and Week 16
Secondary	Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16		Baseline and Week 16
Secondary	Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16		Baseline and Week 16