A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01934582
First received: August 29, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: UT-15 SR (treprostinil diethanolamine)
Drug: treprostinil diethanolamine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15 SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • To assess the pharmacokinetics of BID and TID dosing in subjects transitioning o this dosage regimen in study TDE-PH-304. [ Time Frame: Subjects will be enrolled for up to 50 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess 6MW distance for both groups (BID and TID) 3-6 hours post morning dose. [ Time Frame: Subjects will be enrolled for up to 50 days. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To compare the adverse event profile of twice daily (BID) versus three times daily (TID) dosing. [ Time Frame: Subjects will be enrolled up to 50 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label extension Drug: UT-15 SR (treprostinil diethanolamine) Drug: treprostinil diethanolamine
Open label study drug.
Other Name: UT-15C Sustained Release (SR)

Detailed Description:

As noted above in "Brief Summary".

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Only subjects who are eligible for and have entered into Protocol TDE-PH-304 may participate in this substudy.

Exclusion Criteria:

  1. The subject must voluntarily give informed consent to participate in the substudy.
  2. No dose changes to study drug are made within 5 days of the pharmacokinetic (PK)substudy visits.
  3. No additions or deletions to concurrent medications are made within 7 days of the pharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants are permitted.
  4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior to the BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure a trough level of study drug for PK sampling.
  5. Subject dosing of study drug on the day of PK sampling must be observed in the clinic by study personnel.
  6. Subject has not experienced a significant loss of blood (> 450 mL) within the last 6 weeks of the pharmacokinetic substudy visit.
  7. The subject must not be receiving any CYP 2C8 inducers or inhibitors
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01934582

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14623
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: James R White, MD, PhD University of Rochester
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01934582     History of Changes
Other Study ID Numbers: TDE-PH-309, TDE-PH-304
Study First Received: August 29, 2013
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014