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FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Primary Purpose

Pulmonary Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
UT-15C 1 mg
UT-15C 0.25 mg
UT-15C 5 mg
Placebo
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18 and 70 years of age, inclusive
  • Body weight at least 50 kilograms
  • PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
  • Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved PAH therapy.
  • Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
  • Reliable and cooperative with protocol requirements.

Exclusion Criteria:

  • Nursing or pregnant.
  • Received a prostacyclin within the past 30 days.
  • PAH due to conditions other than noted in the above inclusion criteria.
  • History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
  • Use of an investigational drug within 30 days of Baseline

Sites / Locations

  • University of Alabama Birmingham
  • West Los Angeles VA Healthcare Center
  • UC Davis Medical Center
  • Stanford University
  • Pulmonary Hypertension Clinic
  • University of Iowa Health Care
  • Kansas University Medical Center
  • Maine Medical Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • University of Minnesota
  • Mayo Clinic
  • Washington University Hospital
  • Weill Cornell Medical Center
  • Columbia Presbyterian Medical Center
  • Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
  • Duke University Medical Center
  • University Hospitals of Cleveland
  • The Cleveland Clinic Foundation
  • Ohio State University
  • Lagacy Clinic Northwest
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • University of Texas Southwestern
  • Intermountain Medical Center
  • Inova Fairfax Hospital
  • St. Vincent's Hospital
  • Prince Charles Hospital
  • The Alfred Hospital
  • Instituto Nacional de Cardiologia
  • Unidad de Investigacion Clinica en Medicina (UDICEM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

UT-15C 0.25 mg

UT-15C 1 mg

UT-15C 5 mg

Arm Description

placebo

UT-15C 0.25 mg

UT-15C 1 mg

UT-15C 5 mg

Outcomes

Primary Outcome Measures

Change in six-minute walk distance from Baseline to Week 12

Secondary Outcome Measures

Borg Dyspnea Score
Clinical Worsening Assessment
Dyspnea Fatigue Index
Symptoms of PAH
World Health Organization (WHO) Functional Class
Trough 6-Minute Walk Distance
Trough Borg Dyspnea Score
Pro-B-type natriuretic peptide (Pro-BNP)
Optional hemodynamic parameters
Adverse events
Clinical Laboratory parameters
Electrocardiogram findings

Full Information

First Posted
September 25, 2008
Last Updated
January 29, 2013
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00760916
Brief Title
FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Official Title
FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Study stopped prior to subject enrollment.
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
United Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals. Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Detailed Description
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals. Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
UT-15C 0.25 mg
Arm Type
Active Comparator
Arm Description
UT-15C 0.25 mg
Arm Title
UT-15C 1 mg
Arm Type
Active Comparator
Arm Description
UT-15C 1 mg
Arm Title
UT-15C 5 mg
Arm Type
Active Comparator
Arm Description
UT-15C 5 mg
Intervention Type
Drug
Intervention Name(s)
UT-15C 1 mg
Intervention Description
UT-15C 1 mg
Intervention Type
Drug
Intervention Name(s)
UT-15C 0.25 mg
Intervention Description
UT-15C 0.25 mg
Intervention Type
Drug
Intervention Name(s)
UT-15C 5 mg
Intervention Description
UT-15C 5 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in six-minute walk distance from Baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Borg Dyspnea Score
Time Frame
12 weeks
Title
Clinical Worsening Assessment
Time Frame
12 weeks
Title
Dyspnea Fatigue Index
Time Frame
12 weeks
Title
Symptoms of PAH
Time Frame
12 weeks
Title
World Health Organization (WHO) Functional Class
Time Frame
12 weeks
Title
Trough 6-Minute Walk Distance
Time Frame
12 weeks
Title
Trough Borg Dyspnea Score
Time Frame
12 weeks
Title
Pro-B-type natriuretic peptide (Pro-BNP)
Time Frame
12 weeks
Title
Optional hemodynamic parameters
Time Frame
12 weeks
Title
Adverse events
Time Frame
12 weeks
Title
Clinical Laboratory parameters
Time Frame
12 weeks
Title
Electrocardiogram findings
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18 and 70 years of age, inclusive Body weight at least 50 kilograms PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV. Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved PAH therapy. Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH. Reliable and cooperative with protocol requirements. Exclusion Criteria: Nursing or pregnant. Received a prostacyclin within the past 30 days. PAH due to conditions other than noted in the above inclusion criteria. History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. Use of an investigational drug within 30 days of Baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Laliberte, PharmD
Organizational Affiliation
United Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Pulmonary Hypertension Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14643
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lagacy Clinic Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157-7000
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Prince Charles Hospital
City
Brisbane
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
Instituto Nacional de Cardiologia
City
Mexico City
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina (UDICEM)
City
Monterrey
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

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