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A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

NCT01934582 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-01-03

Study results available
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Summary

A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily dosing regimen.

Conditions

Interventions

DRUG

UT-15C SR

DRUG

treprostinil diethanolamine

Open label study drug.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • James R White, MD, PhD · University of Rochester

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01934582 on ClinicalTrials.gov