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

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants


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

Completion date provided represents the completion date of the grant per OOPD records
Study Started
Oct 31
Study Completion
Sep 30
Last Update
Mar 25



--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


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--


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)


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
No Results Posted