NCT00004497

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 8 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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. Completion date provided represents the completion date of the grant per OOPD records

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	UT-15

Timeline

• Start date: 1998-10-01
• Completion: 2000-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

7 sites across 1 country: United States