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History of Changes for Study: NCT03043651
Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Latest version (submitted September 25, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 2, 2017 None (earliest Version on record)
2 February 6, 2017 Study Status
3 February 15, 2017 Study Status
4 May 4, 2017 Study Status and Contacts/Locations
5 June 5, 2017 Study Status and Contacts/Locations
6 June 13, 2017 Contacts/Locations and Study Status
7 June 21, 2017 Recruitment Status, Contacts/Locations, Study Status and Oversight
8 July 21, 2017 Study Status and Contacts/Locations
9 July 31, 2017 Contacts/Locations and Study Status
10 August 3, 2017 Study Status and Contacts/Locations
11 August 28, 2017 Contacts/Locations and Study Status
12 September 13, 2017 Study Status and Contacts/Locations
13 October 5, 2017 Study Status and Contacts/Locations
14 October 24, 2017 Contacts/Locations and Study Status
15 November 28, 2017 Contacts/Locations and Study Status
16 December 1, 2017 Study Status and Contacts/Locations
17 December 4, 2017 Contacts/Locations and Study Status
18 December 5, 2017 Contacts/Locations and Study Status
19 December 8, 2017 Contacts/Locations and Study Status
20 December 14, 2017 Contacts/Locations and Study Status
21 January 8, 2018 Study Status and Contacts/Locations
22 January 18, 2018 Contacts/Locations and Study Status
23 March 1, 2018 Study Status, Contacts/Locations and Arms and Interventions
24 March 20, 2018 Contacts/Locations and Study Status
25 April 2, 2018 Study Status and Contacts/Locations
26 April 19, 2018 Contacts/Locations and Study Status
27 May 17, 2018 Study Status and Contacts/Locations
28 May 30, 2018 Contacts/Locations and Study Status
29 June 8, 2018 Study Status and Contacts/Locations
30 July 31, 2018 Contacts/Locations and Study Status
31 August 29, 2018 Study Status and Contacts/Locations
32 September 27, 2018 Study Status and Contacts/Locations
33 September 28, 2018 Contacts/Locations and Study Status
34 November 20, 2018 Contacts/Locations and Study Status
35 December 13, 2018 Contacts/Locations and Study Status
36 March 5, 2019 Contacts/Locations and Study Status
37 October 10, 2019 Contacts/Locations and Study Status
38 October 31, 2019 Recruitment Status, Contacts/Locations and Study Status
39 April 16, 2020 Recruitment Status, Study Status and Study Design
40 September 25, 2020 Study Status, Outcome Measures, Arms and Interventions, Eligibility, Study Description, Document Section, Results, Contacts/Locations and Study Identification
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Study NCT03043651
Submitted Date:  February 2, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: TDE-HF-302
Brief Title: Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
Official Title: An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Not yet recruiting
Study Start: December 2017
Primary Completion: December 2021 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: January 31, 2017
First Submitted that
Met QC Criteria:
February 2, 2017
First Posted: February 6, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 2, 2017
Last Update Posted: February 6, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: United Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who have completed Study TDE-HF-301. This study will provide long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil becomes commercially available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.
Detailed Description:
Open or close this module Conditions
Conditions: Pulmonary Hypertension Associated With HFpEF
Keywords: Pulmonary Hypertension
HFpEF
6-Minute Walk Test
Oral Treprostinil
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 310 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration
Drug: Oral Treprostinil
Sustained-release oral tablets for TID administration
Other Names:
  • Treprostinil diethanolamine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with treatment-related adverse events
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

2. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by clinical laboratory parameters
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

3. Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with heart failure signs and symptoms
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

Secondary Outcome Measures:
1. Effect of Continued Long-term Oral Treprostinil Therapy on the 6-Minute Walk Distance (6MWD)
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
2. Effect of Continued Long-term Oral Treprostinil Therapy on the Borg Dyspnea Score
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).
3. Effect of Continued Long-term Oral Treprostinil Therapy on World Health Organization (WHO) Functional Class
[ Time Frame: Baseline through study completion, up to approximately 8 years ]

The WHO functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
4. Effect of Continued Long-term Oral Treprostinil Therapy on the N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP)
[ Time Frame: Baseline to Weeks 24 and 48 ]

The NT-proBNP is a biomarker associated with changes in right heart morphology and function.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 79 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study.

Exclusion Criteria

  • The subject is pregnant or lactating.
  • The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
  • The subject developed a concurrent illness or condition during Study TDE HF 301, which, in the opinion of the Investigator, would represent a risk to the subject's overall health if they enrolled in this study.
Open or close this module Contacts/Locations
Central Contact Person: David B Yehle, RPh
Email: dyehle@unither.com
Central Contact Backup: Derek Solum, PhD
Email: dsolum@unither.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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