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Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

NCT02279745 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-12-22

Study results available
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Summary

This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.

Conditions

Interventions

DRUG

Ralinepag

Active

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-08
Primary Completion
2021-03-29
Completion
2021-03-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279745 on ClinicalTrials.gov