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Trial record 1 of 1 for:    TDE-HF-302
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Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

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ClinicalTrials.gov Identifier: NCT03043651
Recruitment Status : Terminated (Terminated by Sponsor)
First Posted : February 6, 2017
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Hypertension Associated With HFpEF
Intervention Drug: Oral treprostinil
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Treprostinil
Hide Arm/Group Description

Sustained-release tablets for TID administration

Oral Treprostinil: Sustained-release oral tablets for TID administration

Period Title: Overall Study
Started 48
Completed 0
Not Completed 48
Reason Not Completed
Death             1
Progressive Disease             2
Adverse Event             2
Withdrawal by Subject             4
Study Terminated by Sponsor             39
Arm/Group Title Oral Treprostinil
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Sustained-release tablets for TID administration

Oral Treprostinil: Sustained-release oral tablets for TID administration

Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
All Subjects
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
76.0
(46 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
35
  72.9%
Male
13
  27.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
1
   2.1%
Not Hispanic or Latino
47
  97.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  10.4%
White
43
  89.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
Hide Description The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study.
Time Frame Baseline through study completion, up to approximately 25 months
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Hide Analysis Population Description
Safety Population
Arm/Group Title Oral Treprostinil
Hide Arm/Group Description:

Sustained-release tablets for TID administration

Oral Treprostinil: Sustained-release oral tablets for TID administration

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
47
  97.9%
Time Frame The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Treprostinil
Hide Arm/Group Description

Sustained-release tablets for TID administration

Oral Treprostinil: Sustained-release oral tablets for TID administration

All-Cause Mortality
Oral Treprostinil
Affected / at Risk (%)
Total   1/48 (2.08%)    
Hide Serious Adverse Events
Oral Treprostinil
Affected / at Risk (%) # Events
Total   19/48 (39.58%)    
Blood and lymphatic system disorders   
Normochromic normocytic anaemia   1/48 (2.08%)  1
Cardiac disorders   
Cardiac failure   3/48 (6.25%)  3
Cardiac failure acute   2/48 (4.17%)  2
Cardiac failure congestive   2/48 (4.17%)  2
Atrial fibrillation   1/48 (2.08%)  1
Cardio-respiratory arrest   1/48 (2.08%)  1
Cardiomyopathy   1/48 (2.08%)  1
Sinus bradycardia   1/48 (2.08%)  1
Sinus node dysfunction   1/48 (2.08%)  1
Tachyarrhythmia   1/48 (2.08%)  1
Gastrointestinal disorders   
Diarrhoea   1/48 (2.08%)  1
Gastrointestinal angiectasia   1/48 (2.08%)  1
Melaena   1/48 (2.08%)  1
General disorders   
Chest pain   1/48 (2.08%)  1
Death   1/48 (2.08%)  1
Infections and infestations   
Pneumonia   2/48 (4.17%)  3
Endocarditis   1/48 (2.08%)  1
Pneumonia mycoplasmal   1/48 (2.08%)  1
Sepsis   1/48 (2.08%)  1
Urinary tract infection   1/48 (2.08%)  1
Injury, poisoning and procedural complications   
Hip fracture   1/48 (2.08%)  1
Investigations   
Electrocardiogram QT prolonged   1/48 (2.08%)  1
Metabolism and nutrition disorders   
Hypokalaemia   2/48 (4.17%)  2
Fluid overload   1/48 (2.08%)  1
Hypervolaemia   1/48 (2.08%)  1
Hypochloraemia   1/48 (2.08%)  1
Nervous system disorders   
Cerebrovascular accident   1/48 (2.08%)  1
Headache   1/48 (2.08%)  1
Metabolic encephalopathy   1/48 (2.08%)  1
Syncope   1/48 (2.08%)  1
Psychiatric disorders   
Confusional state   1/48 (2.08%)  1
Renal and urinary disorders   
Acute kidney injury   4/48 (8.33%)  5
Azotaemia   1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure   2/48 (4.17%)  2
Pleural effusion   2/48 (4.17%)  3
Chronic obstructive pulmonary disease   1/48 (2.08%)  1
Dyspnoea   1/48 (2.08%)  1
Pulmonary hypertension   1/48 (2.08%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Treprostinil
Affected / at Risk (%) # Events
Total   47/48 (97.92%)    
Blood and lymphatic system disorders   
Anaemia   3/48 (6.25%)  3
Cardiac disorders   
Atrial fibrillation   4/48 (8.33%)  6
Cardiac failure   3/48 (6.25%)  4
Palpitations   3/48 (6.25%)  3
Ear and labyrinth disorders   
Vertigo   3/48 (6.25%)  3
Gastrointestinal disorders   
Diarrhoea   26/48 (54.17%)  28
Nausea   17/48 (35.42%)  20
Dyspepsia   6/48 (12.50%)  6
Abdominal pain   4/48 (8.33%)  4
Constipation   4/48 (8.33%)  4
Vomiting   4/48 (8.33%)  5
Abdominal distension   3/48 (6.25%)  3
Flatulence   3/48 (6.25%)  3
General disorders   
Fatigue   15/48 (31.25%)  17
Oedema peripheral   9/48 (18.75%)  9
Chest pain   5/48 (10.42%)  6
Oedema   4/48 (8.33%)  4
Infections and infestations   
Pneumonia   5/48 (10.42%)  6
Upper respiratory tract infection   5/48 (10.42%)  5
Sinusitis   4/48 (8.33%)  4
Urinary tract infection   3/48 (6.25%)  4
Viral upper respiratory tract infection   3/48 (6.25%)  4
Investigations   
Blood creatinine increased   5/48 (10.42%)  5
Blood alkaline phosphatase increased   3/48 (6.25%)  3
Gamma-glutamyltransferase increased   3/48 (6.25%)  3
N-terminal prohormone brain natriuretic peptide increased   3/48 (6.25%)  3
Metabolism and nutrition disorders   
Decreased appetite   4/48 (8.33%)  4
Musculoskeletal and connective tissue disorders   
Pain in extremity   13/48 (27.08%)  20
Back pain   8/48 (16.67%)  8
Pain in jaw   7/48 (14.58%)  7
Arthralgia   6/48 (12.50%)  8
Muscle spasms   5/48 (10.42%)  5
Musculoskeletal pain   3/48 (6.25%)  3
Myalgia   3/48 (6.25%)  4
Nervous system disorders   
Headache   31/48 (64.58%)  35
Dizziness   9/48 (18.75%)  10
Presyncope   3/48 (6.25%)  3
Renal and urinary disorders   
Acute kidney injury   5/48 (10.42%)  7
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   9/48 (18.75%)  10
Cough   8/48 (16.67%)  8
Pleural effusion   3/48 (6.25%)  4
Skin and subcutaneous tissue disorders   
Rash   4/48 (8.33%)  4
Vascular disorders   
Flushing   5/48 (10.42%)  5
Hypotension   4/48 (8.33%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the study without the prior written consent of the Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Louis Holdstock
Organization: United Therapeutics
Phone: 919-425-8866
EMail: lholdstock@unither.com
Layout table for additonal information
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT03043651    
Other Study ID Numbers: TDE-HF-302
First Submitted: January 31, 2017
First Posted: February 6, 2017
Results First Submitted: September 25, 2020
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020