Hypertension, PulmonaryPhase 4NCT00643604
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
A Phase 4 study testing treprostinil sodium in people with Hypertension, Pulmonary, run by United Therapeutics at 1 site in United States.
Trial summary
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- treprostinil sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 years and 70 years of age
- Be male or if female, be physiologically incapable of childbearing or practicing an acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).
- Have a current World Health Organization (WHO) functional classification of II-III status
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
- In the opinion of the investigator, be hemodynamically stable with no signs or symptoms of disease progression
- Be receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month prior to Baseline.
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- Have a central intravenous catheter in place.
- Have a baseline six-minute walk distance of at least 150 meters.
- Be optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month prior to baseline assessments.
- Be mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Who cannot join
- Be a nursing or pregnant woman
- Have had 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.
- Have any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Have an on-going central venous line infection within the past 30 days.
- Have evidence of predominant left-sided heart disease
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- Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
- Have 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.
- Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Have the presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Read the detailed description
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 IV and 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. Furthermore, 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 using the CADD legacy pump.
- Conditions
- Hypertension, Pulmonary
- Being tested
- treprostinil sodium
- Keywords
- Pulmonary arterial hypertension, treatment satisfaction, rapid switch, remodulin, Quality of life
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil sodiumDrug
Also called Remodulin, Flolan
rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
| Study group | Role | What they receive |
|---|---|---|
| treprostinil sodium | Experimental | all subjects had switched from IV epoprostenol to IV treprostinil sodium Receives: Drug: treprostinil sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six Minute Walk Distance
Measured: Baseline and Week 8
Secondary outcomes (13)
Change in WHO Functional Classification
Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
Measured: Baseline and Week 8
Change in Borg Dyspnea Score Immediately After Six Minute Walk
The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Measured: Baseline and Week 8
Change in Score on 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 quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.
Measured: Baseline and Week 8
Change in Score on Treatment Satisfaction Questionnaire for Medication
The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.
Measured: Baseline and Week 8
Change in 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. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities
Measured: Baseline and Week 8
Change in PAH Signs and Symptoms- Fatigue
The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change From in Signs and Symptoms of PAH- Edema
The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Signs and Symptoms of PAH- Dyspnea
The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Signs and Symptoms of PAH- Orthopnea
The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Signs and Symptoms of PAH- Dizziness
The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Signs and Symptoms of PAH- Syncope
The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Change in Signs and Symptoms of PAH- Chest Pain
The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Measured: Baseline and Week 8
Patient Impression of Change Questionnaire
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionFeb 2012
Why it stopped: Due to availability of eligible subjects at center and enrollment competition with other studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Tapson, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643604
- Sponsor's protocol ID
- RIV-PH-413
- Status last verified
- Jun 2013
- First submitted
- 20 Mar 2008
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction
- ClinicalTrials.gov ID
- NCT00643604
- Acronym / sponsor ID
- RIV-PH-413
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary arterial hypertension, treatment satisfaction, rapid switch, remodulin, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to availability of eligible subjects at center and enrollment competition with other studies.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 21 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Detailed description
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 IV and 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. Furthermore, 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 using the CADD legacy pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treprostinil sodium | Experimental | Drug: treprostinil sodiumall subjects had switched from IV epoprostenol to IV treprostinil sodium |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be between 18 years and 70 years of age
- Be male or if female, be physiologically incapable of childbearing or practicing an acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).
- Have a current World Health Organization (WHO) functional classification of II-III status
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
- In the opinion of the investigator, be hemodynamically stable with no signs or symptoms of disease progression
Key exclusion criteria (11 listed)
- Be a nursing or pregnant woman
- Have had 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.
- Have any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Have an on-going central venous line infection within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treprostinil sodiumAlso: Remodulin, Flolanrapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium | Drug | treprostinil sodium |
Primary outcome
Change in Six Minute Walk Distance
Time frame: Baseline and Week 8
13 secondary outcomes
Change in WHO Functional Classification
Time frame: Baseline and Week 8
Change in Borg Dyspnea Score Immediately After Six Minute Walk
Time frame: Baseline and Week 8
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Time frame: Baseline and Week 8
Change in Score on Treatment Satisfaction Questionnaire for Medication
Time frame: Baseline and Week 8
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time frame: Baseline and Week 8
Change in PAH Signs and Symptoms- Fatigue
Time frame: Baseline and Week 8
Change From in Signs and Symptoms of PAH- Edema
Time frame: Baseline and Week 8
Change in Signs and Symptoms of PAH- Dyspnea
Time frame: Baseline and Week 8
Change in Signs and Symptoms of PAH- Orthopnea
Time frame: Baseline and Week 8
Change in Signs and Symptoms of PAH- Dizziness
Time frame: Baseline and Week 8
Change in Signs and Symptoms of PAH- Syncope
Time frame: Baseline and Week 8
Change in Signs and Symptoms of PAH- Chest Pain
Time frame: Baseline and Week 8
Patient Impression of Change Questionnaire
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Tapson, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing treprostinil sodium in people with Hypertension, Pulmonary, run by United Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six Minute Walk Distance (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.