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Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

NCT01560624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2020-02-13

Study results available
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Summary

This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

Conditions

Interventions

DRUG

Treprostinil Diolamine

Active

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • James White, MD, PhD · Mary M. Parkes Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-26
Primary Completion
2018-06-24
Completion
2018-06-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Chile
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Singapore
  • South Korea
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01560624 on ClinicalTrials.gov