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

This study has been completed.
Sponsor:
Collaborator:
United Therapeutics
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004497
First received: October 18, 1999
Last updated: May 29, 2007
Last verified: September 1999
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Pulmonary Hypertension
Drug: UT-15
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Study Start Date: October 1998
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center and etiology of disease.

Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks.

After completing 12 weeks of treatment, patients may continue therapy with open label UT-15. Patients who received placebo cross over to receive UT-15.

  Eligibility

Ages Eligible for Study:   8 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004497

Locations
United States, California
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
United States, North Carolina
United Therapeutics Corporation
Research Triangle Park, North Carolina, United States, 27709
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2516
Sponsors and Collaborators
United Therapeutics
Investigators
Study Chair: James Walker Crow United Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004497     History of Changes
Other Study ID Numbers: 199/14287, UTC-FDR001545, UTC-P01-04
Study First Received: October 18, 1999
Last Updated: May 29, 2007
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
hypertensive disorder
primary pulmonary hypertension
rare disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014