Safety of Transition From Selexipag to Remodulin® Then Or... | NCT03016468

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

NCT03016468

Sponsor

United Therapeutics

Status

Withdrawn

Last Update Posted

Apr 11, 2017Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Pulmonary Arterial Hypertension

Interventions

Parenteral Remodulin (treprostinil) injection
Oral Treprostinil

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision

Expanded Access Info

Start Date

May 2017Estimated

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Jan 6, 2017

First Submission Date that Met QC Criteria

Jan 6, 2017

First Posted Date

Jan 10, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2017

Last Update Posted Date

Apr 11, 2017Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parenteral Remodulin then Oral Treprostinil	Experimental		Drug: Parenteral Remodulin (treprostinil) injection Drug: Oral Treprostinil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parenteral Remodulin (treprostinil) injection	Drug	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.

Measure	Description	Time Frame
Incidence of Adverse Events (AEs) through 16 Weeks		16 Weeks

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
The subject must be classified as WHO FC II or III at Baseline.
The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.
Subject is in need of escalation of therapy, as determined by the Investigator.
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:

The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.
The subject has a Baseline 6MWD of less than 150 meters.
The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.
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%.
The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C427248	treprostinil
D007267	Injections

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics