Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)

NCT00147199 | Completed Phase 3 Results

• 1 other identifier: LRX-TRIUMPH 001
• Study Type: interventional
• Target: 235
• Locations: 10 countries
• Sites: 30

Brief Summary

This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Peak 6-minute Walk Distance

  Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation

  12 weeks

Secondary Outcomes (8)

• Clinical Worsening Events

  12 weeks

• Borg Dyspnea Score

  12 weeks

• New York Heart Association (NYHA) Functional Classification

  12 weeks

• Trough 6MWD at Week 12

  12 Weeks

• Peak 6MWD at Week 6

  6 weeks

Study Arms (2)

Inhaled treprostinil

EXPERIMENTAL

0.9 mg/mL treprostinil for inhalation supplied in 2.9mL ampoules for use in ultra sonic nebulizer

Drug: Inhaled treprostinil

Placebo

PLACEBO COMPARATOR

Placebo inhalation solution for use in ultrasonic nebulizer

Drug: Placebo inhalation solution

Interventions

Inhaled treprostinil DRUG

Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.

Also known as: Tyvaso

Inhaled treprostinil

Placebo inhalation solution DRUG

Doses are titrated to 9 breaths four times daily.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable, pulmonary arterial hypertension diagnosed as either idiopathic or familial PAH, collagen vascular disease associated PAH, HIV PAH, or PAH induced by anorexigens, New York Heart Association (NYHA) Class III or Class IV.
• Been on a stable dose of 125 mg twice daily (bid) of bosentan OR any stable dose of sildenafil for at least three months prior to study start
• An unencouraged six minute walk test (6MWT) of between 200 and 450 meters at screening
• Cardiac catheterization within the past 13 months consistent with PAH, specifically mean pulmonary artery pressure (PAPm) ≥25 mmHg (at rest), pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤15 mmHg, and pulmonary vascular resistance (PVR) \>3 mmHg/L/min
• Within the past 12 months, patients must have had a chest radiograph consistent with the diagnosis of PAH
• Willing and able to follow all study procedures

You may not qualify if:

• Considering pregnancy, are pregnant and/or lactating
• Have had any change in or discontinued any PAH medication within the last three months, including but not limited to endothelin receptor antagonist (ERA), or calcium channel blockers (CCB) (with the exception of anticoagulants)
• Have received any prostanoid within the 30 days before screening or are scheduled to receive any during the course of the study
• Have received any investigational medication within 30 days prior to the start of this study or are scheduled to receive another investigational drug during the course of this study
• Have a known intolerance to any drug, especially to treprostinil sodium or prostanoids
• Have an increased risk of hemorrhage
• Have a new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, except anticoagulants
• Have any musculoskeletal disease or any other disease that would limit ambulation.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (30)

University of Alabama

Birmingham, Alabama, 35294-0006, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

UCSD Medical center

La Jolla, California, 92037, United States

Location

UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Orlando Heart Center

Orlando, Florida, 32806, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5853, United States

Location

Bethe Israel Medical Center

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2650, United States

Location

UTSW Medical Center

Dallas, Texas, 75235, United States

Location

Universitatsklinikfur Innere Medizin II

Wein, Vienna, 1090, Austria

Location

Medical University Graz

Graz, Austria

Location

Universite Libre de Bruxelles

Brussels, 1070, Belgium

Location

University Hospital Gasthuisburg

Leuven, Belgium

Location

Hospital Antoine Beclere

Paris, 92141, France

Location

Univesitatsklinikum Giessen und Marburg GmbH

Geißen, D-35392, Germany

Location

Pulmonary Hypertension Unit

Dublin, Ireland

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

The Pulmonary Institute

Jerusalem, Israel

Location

The Pulmonary Institute

Petach Tikvah 49100, Israel

Location

Instituto Malattie dell'Apparato Vascolare

Bologna, Italy

Location

University of Barcelona

Barcelona, 08036, Spain

Location

Papworth Hospital

Cambridge, CB3 8RE, United Kingdom

Location

Scottish Pulmonary Vascular Unit

Glasgow GII 6NT, United Kingdom

Location

Royal Fee Hospital

London, United Kingdom

Location

Related Publications (1)

• McLaughlin VV, Benza RL, Rubin LJ, Channick RN, Voswinckel R, Tapson VF, Robbins IM, Olschewski H, Rubenfire M, Seeger W. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1915-22. doi: 10.1016/j.jacc.2010.01.027.

  PMID: 20430262 DERIVED

Related Links

• The mission of the Pulmonary Hypertension Association is to seek a cure, and to provide hope, support and education, and to promote awareness and to advocate for the pulmonary hypertension community.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: United Therapeutics Corp.

clinicaltrials@unither.com

919-485-8350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 2, 2024
• Results First Posted: August 12, 2013

Record last verified: 2013-07

Locations

US (15); GB (3); IT (1); AU (2); DE (1); IE (1); BE (2); FR (1); IL (3); ES (1)