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This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Treprostinil | Experimental | Intravenous treprostinil was supplied as 1 mg/mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Treprostinil | Drug | Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) | The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. | The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit |
| Effect of Long-term Remodulin Therapy on the NYHA Functional Classification | The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment). | The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit |
| Effect of Long-term Remodulin Therapy on Subject Safety | Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination). | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Treprostinil | Intravenous treprostinil was supplied as 1 mg/mL. Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Treprostinil | Intravenous treprostinil was supplied as 1 mg/mL. Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) | The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. | Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit. | Posted | Mean | Standard Deviation | Meters | The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit |
|
Baseline to each subject's last visit, assessed up to approximately 9 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Treprostinil | Intravenous treprostinil was supplied as 1 mg/mL. Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyanosis | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | United Therapeutics Corp. | 919-485-8350 | clinicaltrials@unither.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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|
| Physician Decision |
|
| Study terminated by Sponsor |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Effect of Long-term Remodulin Therapy on the NYHA Functional Classification | The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment). | Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit. | Posted | Mean | Standard Deviation | Functional Class | The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit |
|
|
|
| Primary | Effect of Long-term Remodulin Therapy on Subject Safety | Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination). | Intent-to-Treat Population | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
|
|
| 6 |
| 16 |
| 14 |
| 16 |
| 14 |
| 16 |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Device dislocation | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Device-related infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Device-related sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Localized infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Polymenorrhea | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Gynacomastia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Device dislocation | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
|
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the Study without the prior written consent of 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.