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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 : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation

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: 78 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 : June 2020
Estimated Study Completion Date : June 2020


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 78 ]

Secondary Outcome Measures :
  1. To assess treatment-related outcomes during routine clinical care. [ Time Frame: Baseline to Week 78 ]
    eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC]

  2. To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest [ Time Frame: Baseline to Week 78 ]
  3. Use of concomitant medications [ Time Frame: Baseline to Week 78 ]
  4. To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies [ Time Frame: Baseline to Week 78 ]
  5. Healthcare resource utilization trends [ Time Frame: Baseline to Week 78 ]
  6. Health-related quality of life in PAH and treatment satisfaction [ Time Frame: Baseline to Week 78 ]
  7. To evaluate reasons for discontinuation of Orenitram [ Time Frame: Baseline to Week 78 ]
  8. To evaluate titration and dosing schedules of Orenitram [ Time Frame: Baseline to Week 78 ]

Biospecimen Retention:   Samples With DNA
  1. Optional evaluation of biomarkers
  2. Optional evaluation of pharmacogenomics


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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 182 or fewer days.
Criteria

INCLUSION CRITERIA

Patients are eligible for the registry if:

  1. The patient voluntarily gives informed consent to participate in the study.
  2. The patient must be at least 18 years of age or older.
  3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days.
  4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study.
  5. The patient has the ability to answer surveys and use the diary in English.
  6. The patient must have an email address and be willing to access the PRO Portal.

EXCLUSION CRITERIA

Patients are ineligible for the registry if:

  1. The patient has previously received Orenitram for more than 182 days.
  2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within

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

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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: October 8, 2018
Last Verified: October 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