Pulmonary Arterial HypertensionPhase 4NCT00058929
A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension
A Phase 4 study testing treprostinil sodium in people with Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by United Therapeutics at 8 sites in United States.
Trial summary
This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Pulmonary Hypertension
- What is being tested?
- treprostinil sodium
- How many people
- 39 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2002to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must:
- Be between 18 years and 75 years of age.
- If female, be physiologically incapable of childbearing or practicing an acceptable method of birth control.
- Have a current confirmed diagnosis of WHO Functional Class II or III pulmonary arterial hypertension (either PPH or PAH associated with the scleroderma spectrum of diseases).
- Have been clinically stable with regard to signs and symptoms of PAH for at least the last 30 days.
- Have a baseline six-minute walk distance of at least 250 meters.
Show all 10Show fewer
- Have been receiving Flolan therapy for at least 6 months, and have documented clinical benefit from Flolan therapy on an exercise assessment.
- Be receiving Flolan at a dose of at least 15 ng/kg/min, but not more than 75 ng/kg/min, and have maintained the current dose of Flolan unchanged for at least 30 days at screening.
- Unless contraindicated, be able to receive one of the following anticoagulants: warfarin to achieve an INR between 2.0 and 3.0 or heparin to produce an aPTT between 1.3 to 1.5 times control, unless higher levels are clinically indicated.
- Be mentally and physically capable of learning to administer study drug using an subcutaneous infusion pump.
Who cannot join
- Patients must not:
- Be a nursing or pregnant woman (women of childbearing potential must have a negative serum pregnancy test).
- Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for pulmonary hypertension added within the last month.
- Have any pulmonary hypertension medication except for anticoagulants discontinued within the week prior to study entry.
- Have ever received Remodulin or any other prostaglandin/prostacyclin analog other than Flolan or Beraprost; or have received Bosentan or any other endothelin receptor antagonist within the past 30 days.
- Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months as follows (any one of the following):
Show all 32Show fewer
- Total Lung Capacity < 60% (predicted), or
- If Total Lung Capacity is between 60% and 70% (predicted), a High Resolution CT scan must be performed to document diffuse interstitial fibrosis or alveolitis, or
- FEV/FVC ratio < 50%, or
- All Scleroderma patients must have Pulmonary Function Test performed within six weeks prior to study entry.
- Be positive for HIV.
- Have Portal Hypertension.
- Have a history of uncontrolled Sleep Apnea within the past three months.
- Have a history of left-sided heart disease including:
- Aortic or mitral valve disease or,
- Pericardial constriction or,
- Restrictive or congestive cardiomyopathy.
- Have evidence of current left-sided heart disease as defined by:
- PCWPm or left ventricular end diastolic pressure > 15 mmHg or
- LVEF < 40% by MUGA or Angiography or echocardiography or
- LV Shortening Fraction < 22% by echocardiography or
- Symptomatic coronary disease (demonstrable ischemia).
- Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic to pulmonary shunt, 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 systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Have used prescription appetite suppressants within 3 months of study entry.
- Have chronic renal insufficiency as defined by creatinine greater than 3.5 mg/dL or the requirement for dialysis.
- 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 had an atrial septostomy.
- Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
- Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
- Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial, or any condition which in the investigator's opinion would constitute an unacceptable risk to the patient's safety.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48106
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Rush Heart Institute Center for Pulmonary Heart Disease
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Baylor College of Medicine
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
LDS Hospital
Salt Lake City, Utah, 84143
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension
This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases.
Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug.
Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
Read the detailed description
This trial is a multicenter, randomized, parallel placebo-controlled study of Remodulin in patients with pulmonary arterial hypertension with WHO Functional Class II or III clinical status who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases.
Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be randomized to study drug (1:1 Remodulin:placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will be done according to a recommended schedule, which may be modified if necessary according to the patient's clinical status. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug, or until the patient has met the primary endpoint criteria.
Patients who are transitioned off Flolan, who are stable on study drug, and who have demonstrated the ability to properly self-administer study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. At weeks other than Weeks 1, 4, and 8, the site staff will contact the patient to assess progress and adjust the study drug dose if necessary. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
- Being tested
- treprostinil sodium
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startOct 2002
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058929
- Sponsor's protocol ID
- P01:13
- Status last verified
- Mar 2013
- First submitted
- 14 Apr 2003
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00058929
- Acronym / sponsor ID
- P01:13
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 16 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases.
Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug.
Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
Detailed description
This trial is a multicenter, randomized, parallel placebo-controlled study of Remodulin in patients with pulmonary arterial hypertension with WHO Functional Class II or III clinical status who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases.
Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be randomized to study drug (1:1 Remodulin:placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will be done according to a recommended schedule, which may be modified if necessary according to the patient's clinical status. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug, or until the patient has met the primary endpoint criteria.
Patients who are transitioned off Flolan, who are stable on study drug, and who have demonstrated the ability to properly self-administer study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. At weeks other than Weeks 1, 4, and 8, the site staff will contact the patient to assess progress and adjust the study drug dose if necessary. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be between 18 years and 75 years of age.
- If female, be physiologically incapable of childbearing or practicing an acceptable method of birth control.
- Have a current confirmed diagnosis of WHO Functional Class II or III pulmonary arterial hypertension (either PPH or PAH associated with the scleroderma spectrum of diseases).
- Have been clinically stable with regard to signs and symptoms of PAH for at least the last 30 days.
- Have a baseline six-minute walk distance of at least 250 meters.
Key exclusion criteria (32 listed)
- Be a nursing or pregnant woman (women of childbearing potential must have a negative serum pregnancy test).
- Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for pulmonary hypertension added within the last month.
- Have any pulmonary hypertension medication except for anticoagulants discontinued within the week prior to study entry.
- Have ever received Remodulin or any other prostaglandin/prostacyclin analog other than Flolan or Beraprost; or have received Bosentan or any other endothelin receptor antagonist within the past 30 days.
- Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months as follows (any one of the following):
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 sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites 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 Pulmonary Arterial Hypertension and Pulmonary Hypertension, run by United Therapeutics at 8 sites 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 32 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: finished, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 7 Mar 2013.