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

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: NCT03016468
Recruitment Status : Withdrawn (Business decision)
First Posted : January 10, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Parenteral Remodulin (treprostinil) injection Drug: Oral Treprostinil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Parenteral Remodulin then Oral Treprostinil 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.
Other Name: Remodulin

Drug: 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.
Other Name: Orenitram




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) through 16 Weeks [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  1. Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
  2. Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
  3. Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
  4. Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
  5. Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03016468    
Other Study ID Numbers: TDE-PH-207
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by United Therapeutics:
Oral Treprostinil
Remodulin
Selexipag
6 Minute Walk Test
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents