Not provided
Not provided
Not provided
Not provided
Not provided
Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH, and to improve health related quality of life (HRQOL).
Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the intravenous (IV) and subcutaneous (SC) routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller pump called the Crono Five.
Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treprostinil | Experimental | IV treprostinil continuous infusion via Crono Five infusion pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treprostinil | Drug | rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD) | The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002]. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition). | Week 8 |
| Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification |
Not provided
Inclusion Criteria:
Age 18 to 65 years
Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
Group 1 pulmonary arterial hypertension
Idiopathic pulmonary arterial hypertension (IPAH)
Familial pulmonary arterial hypertension (FPAH)
Associated pulmonary arterial hypertension (APAH):
Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
WHO Class II-III
Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
Have central intravenous catheter
Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion Criteria:
nursing or pregnant woman
received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month.
Had any PAH medication discontinued within the week prior to study entry.
Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Had a central venous line infection within the past 30 days.
Previous documented evidence of significant parenchymal lung disease as evidenced by pulmonary function tests as follows (any one of the following):
History of or evidence of left-sided heart disease
Having any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
Having a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
Uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater than 160 millimeters of mercury (mmHg) or diastolic blood pressure greater than 100 mmHg.
Chronic renal insufficiency as defined by serum creatinine greater than 2.5 milligrams per deciliter (mg/dL) or the requirement for dialysis.
Receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
Active infection, or any other ongoing condition that would interfere with the interpretation of study assessments.
The presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Remzi Bag, MD | INTEGRIS Baptist Medical Center | Principal Investigator |
| Evelyn Horn, MD | Weill Medical College of Cornell University | Principal Investigator |
| Teresa DeMarco, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco (UCSF) Medical Center | San Francisco | California | 94143 | United States | ||
A total of ten subjects were screened. Eight were enrolled and completed the study. One subject withdrew their consent prior to enrolling. The second subject failed screening due to low hemoglobin levels. Once enrolled, baseline assessments were completed, and patients underwent rapid switch from epoprostenol to treprostinil infusion.
Screening was initiated by investigators at participating study sites 7 to 28 days prior to the Baseline visit. The first subject was enrolled on February 20, 2007 and the last subject completed the study on September 30, 2009. After an extended recruitment period during which no new subjects were enrolled, the study was closed in 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treprostinil | All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability. treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Crono Five ambulatory pump | Device | Used for administration of IV Remodulin (treprostinil) |
|
WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class. |
| Week 8 |
| Change From Baseline at Week 8 in Symptoms of PAH- Fatigue | The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea | The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in Symptoms of PAH- Edema | The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in PAH Symptoms- Orthopnea | The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in PAH Symptoms- Dizziness | The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in PAH Symptoms- Syncope | The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe. | Week 8 |
| Change From Baseline at Week 8 in PAH Symptoms- Chest Pain | The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe. | Week 8 |
| Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. | Week 8 |
| Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) | The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options. The CAMPHOR score range can be from 0 to 80. A reduction in score denotes improved heath status. | Baseline and Week 8 |
| Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM) | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions). With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied). A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17. The TSQM score range can be from 0 to 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction. | Baseline and Week 8 |
| Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only) | A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions. | Week 8 |
| THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center |
| New York |
| New York |
| 10065 |
| United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73122 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treprostinil | All Subjects transitioned from IV epoprostenol to IV treprostinil. treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Pulmonary Arterial Hypertension (PAH) etiology | Number | participants |
| |||||||||||||||||||||||
| Years since PAH diagnosis | Mean | Full Range | years |
| ||||||||||||||||||||||
| World Health Organization (WHO) functional class at time of transition | WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class. | Number | participants |
| ||||||||||||||||||||||
| epoprostenol dose | Mean | Full Range | ng/kg/min |
| ||||||||||||||||||||||
| Baseline 6 Minute Walk Distance (6MWD) | This measure includes 6 patients. Two subjects did not have Baseline 6-Minute Walk Tests (6MWTs) conducted. | Mean | Full Range | meters |
|
| 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 | Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD) | The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002]. | Two subjects did not have Baseline 6MWTs and were excluded from this analysis. | Posted | Mean | Standard Deviation | meters | Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition). | Two subjects did not have Baseline Borg scores and were excluded from this analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification | WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included. | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Symptoms of PAH- Fatigue | The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included. | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea | The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Symptoms of PAH- Edema | The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in PAH Symptoms- Orthopnea | The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in PAH Symptoms- Dizziness | The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included. | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in PAH Symptoms- Syncope | The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included. | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in PAH Symptoms- Chest Pain | The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe. | All Subjects transitioned from IV epoprostenol to IV treprostinil were included. | Posted | Number | participants | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. | Posted | Mean | Standard Deviation | minutes | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) | The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options. The CAMPHOR score range can be from 0 to 80. A reduction in score denotes improved heath status. | One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM) | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions). With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied). A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17. The TSQM score range can be from 0 to 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction. | All 8 participants are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only) | A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions. | Posted | Number | participants | Week 8 |
|
|
Adverse Events (AEs) were assessed upon initiation of Remodulin through to the end of study (Week 8)
Since subjects were transitioning from an existing prostacyclin therapy, prostacyclin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treprostinil | All Subjects transitioned from IV epoprostenol to IV treprostinil. treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| central line infection | Infections and infestations | MeDRA 10.0 | Non-systematic Assessment | All events resolved with treatment and subjects continued in the study. The investigator judged the event to be not reasonably attributable to study drug. |
|
| Fluid overload | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment | One subject was hospitalized for two serious adverse events: fluid overload and right ventricular failure. All events resolved with treatment and subjects continued the study. The investigator judged the event reasonably attributable to treprostinil. |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment | All events resolved with treatment and subjects continued in the study. The investigator judged the event to be not reasonably attributable to study drug. |
|
| Right ventricular failure | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Nasal congestion | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pyrexia | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Productive cough | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
The main limitations of this study are the modest sample size and relatively short duration of follow-up.
Any publication of the results of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Remodulin Program Leader | United Therapeutics | (919) 485-8350 | ClinicalRecordsManagement@unither.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|