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ADAPT - A Patient Registry of the Real-world Use of Orenitram® (ADAPT)

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ClinicalTrials.gov Identifier: NCT03045029
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Oral treprostinil

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 52 Weeks
Official Title: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Group/Cohort Intervention/treatment
Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Drug: Oral treprostinil
Sustained-release oral tablets for TID administration
Other Names:
  • Treprostinil diethanolamine
  • Treprostinil diolamine




Primary Outcome Measures :
  1. Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Treatment-related outcomes collected by study sites during routine clinical care [ Time Frame: Baseline to Week 52 ]
  2. Development, timing, severity, and frequency of prostacyclin-related AEs [ Time Frame: Enrollment to Week 52 ]
  3. Use of concomitant medications [ Time Frame: Baseline to Week 52 ]
  4. Reasons for discontinuing Orenitram and information on clinical titration schedules implemented for transition to alternative prostacyclin therapies [ Time Frame: Enrollment to Week 52 ]
  5. Healthcare resource utilization trends [ Time Frame: Baseline to Week 52 ]
  6. Health-related quality of life in PAH and treatment satisfaction [ Time Frame: Baseline to Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are eligible if they have been receiving Orenitram for less than or equal to 21 days or plan to initiate Orenitram therapy
Criteria

Inclusion Criteria:

  1. The patient is newly prescribed on Orenitram, per the package insert indication, and plans to initiate therapy with this medication, or has been receiving Orenitram for 21 or fewer days.
  2. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes and use for the duration of the study.
  3. The patient has the ability to answer surveys, use the diary in English, and has access to the internet.

Exclusion Criteria:

  1. The patient has previously received Orenitram for more than 21 days.
  2. The patient is currently receiving epoprostenol therapy or has received epoprostenol within 30 days of enrollment (except if received during acute vasodilator testing).
  3. The patient is currently participating in an investigational drug or device study within 30 days of enrollment. Co-enrollment in other noninterventional studies is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045029


Contacts
Contact: Bucky Turpin (919) 425-5492 bturpin@unither.com
Contact: Derek Solum, PhD (919) 425-8122 dsolum@unither.com

  Show 40 Study Locations
Sponsors and Collaborators
United Therapeutics

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03045029     History of Changes
Other Study ID Numbers: TDE-PH-401
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United Therapeutics:
PAH
Oral Treprostiinil
Orenitram

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents