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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045029
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Tracking Information
First Submitted Date February 2, 2017
First Posted Date February 7, 2017
Last Update Posted Date July 8, 2020
Actual Study Start Date July 18, 2017
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2018)
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients [ Time Frame: Baseline to Week 78 ]
Original Primary Outcome Measures
 (submitted: February 6, 2017)
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients [ Time Frame: Baseline to Week 52 ]
Change History
Current Secondary Outcome Measures
 (submitted: October 4, 2018)
  • 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]
  • To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest [ Time Frame: Baseline to Week 78 ]
  • Use of concomitant medications [ Time Frame: Baseline to Week 78 ]
  • To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies [ Time Frame: Baseline to Week 78 ]
  • Healthcare resource utilization trends [ Time Frame: Baseline to Week 78 ]
  • Health-related quality of life in PAH and treatment satisfaction [ Time Frame: Baseline to Week 78 ]
  • To evaluate reasons for discontinuation of Orenitram [ Time Frame: Baseline to Week 78 ]
  • To evaluate titration and dosing schedules of Orenitram [ Time Frame: Baseline to Week 78 ]
Original Secondary Outcome Measures
 (submitted: February 6, 2017)
  • Treatment-related outcomes collected by study sites during routine clinical care [ Time Frame: Baseline to Week 52 ]
  • Development, timing, severity, and frequency of prostacyclin-related AEs [ Time Frame: Enrollment to Week 52 ]
  • Use of concomitant medications [ Time Frame: Baseline to Week 52 ]
  • Reasons for discontinuing Orenitram and information on clinical titration schedules implemented for transition to alternative prostacyclin therapies [ Time Frame: Enrollment to Week 52 ]
  • Healthcare resource utilization trends [ Time Frame: Baseline to Week 52 ]
  • Health-related quality of life in PAH and treatment satisfaction [ Time Frame: Baseline to Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Official Title ADAPT - A Patient Registry of the Real-world Use of Orenitram®
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
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 78 Weeks
Biospecimen Retention:   Samples With DNA
Description:
  1. Optional evaluation of biomarkers
  2. Optional evaluation of pharmacogenomics
Sampling Method Non-Probability Sample
Study Population Patients are eligible if they have been receiving Orenitram for 182 or fewer days.
Condition Pulmonary Arterial Hypertension
Intervention Drug: Oral treprostinil
Sustained-release oral tablets for TID administration
Other Names:
  • Treprostinil diethanolamine
  • Treprostinil diolamine
Study Groups/Cohorts Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Intervention: Drug: Oral treprostinil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 6, 2017)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bucky Turpin (919) 425-5492 bturpin@unither.com
Contact: Derek Solum, PhD (919) 425-8122 dsolum@unither.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03045029
Other Study ID Numbers TDE-PH-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party United Therapeutics
Study Sponsor United Therapeutics
Collaborators Not Provided
Investigators Not Provided
PRS Account United Therapeutics
Verification Date July 2020