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FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT00325403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2024-01-03

Study results available
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Summary

This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.

Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Oral treprostinil (UT-15C) Sustained Release Tablets

Sustained release oral tablet, twice daily

OTHER

Placebo

Placebo oral tablet twice daily

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kevin Laliberte, PharmD · United Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico

Study Locations

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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 NCT00325403 on ClinicalTrials.gov