MedTrace Logo

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)

NCT03496623 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-11-24

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

Conditions

Interventions

DRUG

Inhaled treprostinil solution

Treprostinil inhalation solution

DRUG

Placebo solution

Placebo solution

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Director · United Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2022-10-13
Completion
2022-10-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Israel
  • Puerto Rico

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 NCT03496623 on ClinicalTrials.gov