Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension

NCT00004497 | Completed Phase 3

• 3 other identifiers: 199/14287UTC-FDR001545UTC-P01-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

OBJECTIVES: I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.

Conditions

Pulmonary Hypertension

Keywords

cardiovascular and respiratory diseases; hypertensive disorder; primary pulmonary hypertension; rare disease

Interventions

UT-15 DRUG

Eligibility Criteria

• Age: 8 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of moderate to severe precapillary pulmonary hypertension (New York Heart Association class III/IV) unresponsive to attempted use of chronic oral vasodilators for at least 1 month Cardiac catheterization at baseline: Pulmonary artery pressure at least 25 mm Hg AND Pulmonary capillary wedge pressure or left ventricular end diastolic pressure no greater than 15 mm Hg AND Pulmonary vascular resistance greater than 3 mm Hg/L/min Echocardiogram at baseline: Right ventricular hypertrophy or dilation AND Normal left ventricular function AND Absence of mitral valve stenosis Chest radiograph within prior 3 months Clear lung fields OR Multiple patchy interstitial (not diffuse) lung fields AND At least 1 of the following: * Right ventricular enlargement * Prominence of main pulmonary artery * Enlarged hilar vessels * Decreased peripheral vessels No significant parenchymal lung disease within prior 3 months as evidenced by: Total lung capacity no greater than 70% predicted FEV/FVC ratio no greater than 50% Diffuse interstitial fibrosis or alveolitis by high resolution CT if total lung capacity is 70-80% or DLCO less than 60% No chronic thromboembolic disease with clot proximal to lobar bifurcation Baseline exercise capacity at least 50 meters walked in six minutes --Prior/Concurrent Therapy-- Endocrine therapy: * At least 30 days since prior chronic prostaglandin or prostaglandin analogue therapy (including Flolan IV) * No concurrent prostaglandins or prostaglandin analogues Other: * At least 1 month since prior new type of chronic therapy (e.g., different category of vasodilator, diuretic, digoxin) for pulmonary hypertension, except anticoagulants * At least 1 week since discontinuation of prior pulmonary hypertension medication, except anticoagulants * At least 30 days since prior participation in an investigational drug study * No other concurrent investigational drug * No concurrent chronic intravenous or inhaled medications (except oxygen) --Patient Characteristics-- Cardiovascular: * No portal hypertension * No left sided heart disease as defined by: Pulmonary capillary wedge pressure or left ventricular end diastolic pressure greater than 15 mm Hg OR LVEF less than 40% by MUGA or angiography OR LV shortening fraction less than 22% by echocardiography OR Symptomatic coronary disease (demonstrable ischemia) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Mentally and physically capable of using an infusion pump * HIV negative * No other disease associated with pulmonary hypertension (sickle cell anemia, schistosomiasis) * No musculoskeletal disorder (arthritis, artificial leg, etc.) or any disease limiting ambulation, or connected to a nonportable machine * No concurrent physiological condition contraindicating use of UT-15

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (7)

Los Angeles County Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

United Therapeutics Corporation

Research Triangle Park, North Carolina, 27709, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Respiratory Tract Diseases; Hypertension; Familial Primary Pulmonary Hypertension; Rare Diseases

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Walker Crow

  United Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: October 1, 1998
• Study Completion: September 1, 2000
• Last Updated: March 25, 2015

Record last verified: 1999-09

Locations

US (7)