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

Sponsors and Collaborators:	Lung Rx United Therapeutics
Information provided by:	Lung Rx
ClinicalTrials.gov Identifier:	NCT00147199

Purpose

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

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Inhaled Treprostinil Sodium Drug: Placebo inhalation solution	Phase III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: U 62840

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension

Further study details as provided by Lung Rx:

Primary Outcome Measures:

6-minute walk distance, change from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NYHA functional classification [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Borg dyspnea scoring [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Signs and symptoms of PAH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to clinical worsening, first incidence of clinical worsening [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety of chronic therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	235
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2010
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Inhaled Treprostinil Sodium	Drug: Inhaled Treprostinil Sodium Inhaled four times daily
2: Placebo Comparator Placebo inhalation solution four times daily	Drug: Placebo inhalation solution Inhaled four times daily

Detailed Description:

Patients who have 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 will be randomized to either Treprostinil inhalation solution or matching placebo.

Administration of study medication will be performed by inhalation with the OPTINEB™ ultrasonic nebulizer.

The proposed dosing regimen will be four times daily—upon awakening, at midday, evening (dinner time) and bedtime.

After a patient has completed the twelve-week study period, they will be given the option of enrolling into an open-label extension study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically stable, pulmonary arterial hypertension diagnosed as either idiopathic or familial PAH, collagen vascular disease associated PAH, HIV PAH, or PAH induced by anorexigens, 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

Exclusion Criteria:

Considering pregnancy, are pregnant and/or lactating
PAH due to conditions other than noted in the above inclusion criteria.
Have had any change in or discontinued any PAH medication within the last three months, including but not limited to ETRA (endothelin receptor antagonist), or CCB (calcium channel blockers) (with the exception of anticoagulants)
Have received any prostanoid, or phosphodiesterase inhibitor (PDEI), 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 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	United Therapeutics Corp ( Karl Gotzkowsky )
Study ID Numbers:	LRX-70362
Study First Received:	September 2, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00147199
Health Authority:	United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Ireland: Irish Medicines Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Lung Rx:

Pulmonary Arterial Hypertension

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Treprostinil
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2009