Hypertension, PulmonaryPhase 4NCT00458042
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction
A Phase 4 study testing treprostinil sodium in people with Hypertension, Pulmonary, run by United Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- treprostinil sodium
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Nov 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 years and 65 years of age
- WHO Class II-III
- Diagnosis of one of the following Group I WHO clinical classifications: Idiopathic or familial pulmonary arterial hypertension (PAH) or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction or PAH associated with drugs or toxins.
- Receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
- May have discontinued iloprost treatment against medical advice up to thirty days prior to screening
- 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 any PAH medication, other than inhaled iloprost, discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
- Previous history of significant parenchymal lung disease
- Have any other type of PAH including but not limited to PAH related to thrombotic or embolic disease
- Have evidence of left-sided heart disease
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- 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 or chronic renal insufficiency
- Use of an investigational drug within the past 30 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD Medical Center Thornton Hospital
La Jolla, California, 92037
UCSD Medical Center Hillcrest Campus
San Diego, California, 92103
About this study
Official title: Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.
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 quality of life (QOL).
Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion. Ventavis (iloprost)is an inhaled prostacyclin analogue with similar properties to Remodulin. In December 2004, Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension (WHO Group I) for patients with NYHA III or IV symptoms.
As the PAH community gains experience with the use of inhaled Ventavis, questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patient's request related to dissatisfaction with the frequency of daily treatments. This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity, safety, HRQOL and treatment satisfactions.
Participation will last up to 12 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participates will have 4 clinic visits during the study and will spend at least one night in the hospital.
- Conditions
- Hypertension, Pulmonary
- Being tested
- treprostinil sodium
- Keywords
- Ventavis, iloporst, Remodulin, treprostinil, PAH, prostacyclin
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;
Adverse events
Secondary outcomes (7)
Secondary Outcomes: Borg dyspnea score immediately after the six minute walk test;
WHO functional classification;
Symptoms of PAH;
Specific prostacyclin side effects;
Total weekly time spent with specific activities associated with intravenous Remodulin therapy compared to the total weekly time spent on specific activities with inhaled Ventavis;
Score on treatment satisfaction scale;
Score on quality of life questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startMar 2007
- Study completionNov 2007
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyong (Nick) Kim, MD, Principal investigator, UCSD Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458042
- Sponsor's protocol ID
- RIV-PH-412
- Status last verified
- Nov 2007
- First submitted
- 5 Apr 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction
- ClinicalTrials.gov ID
- NCT00458042
- Acronym / sponsor ID
- RIV-PH-412
- Conditions
- Hypertension, Pulmonary
- Keywords
- Ventavis, iloporst, Remodulin, treprostinil, PAH, prostacyclin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Apr 2007 (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.
The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.
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 quality of life (QOL).
Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion. Ventavis (iloprost)is an inhaled prostacyclin analogue with similar properties to Remodulin. In December 2004, Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension (WHO Group I) for patients with NYHA III or IV symptoms.
As the PAH community gains experience with the use of inhaled Ventavis, questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patient's request related to dissatisfaction with the frequency of daily treatments. This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity, safety, HRQOL and treatment satisfactions.
Participation will last up to 12 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participates will have 4 clinic visits during the study and will spend at least one night in the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between 18 years and 65 years of age
- WHO Class II-III
- Diagnosis of one of the following Group I WHO clinical classifications: Idiopathic or familial pulmonary arterial hypertension (PAH) or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction or PAH associated with drugs or toxins.
- Receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
- May have discontinued iloprost treatment against medical advice up to thirty days prior to screening
Key exclusion criteria (9 listed)
- Be a nursing or pregnant woman
- Have any PAH medication, other than inhaled iloprost, discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
- Previous history of significant parenchymal lung disease
- Have any other type of PAH including but not limited to PAH related to thrombotic or embolic disease
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
Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;
Adverse events
7 secondary outcomes
Secondary Outcomes: Borg dyspnea score immediately after the six minute walk test;
WHO functional classification;
Symptoms of PAH;
Specific prostacyclin side effects;
Total weekly time spent with specific activities associated with intravenous Remodulin therapy compared to the total weekly time spent on specific activities with inhaled Ventavis;
Score on treatment satisfaction scale;
Score on quality of life questionnaire
Results and safety
The study was stopped early (reason given: Low Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2007.
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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.
Hyong (Nick) Kim, MD principal investigator
UCSD Medical Center
2 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 Hypertension, Pulmonary, run by United Therapeutics at 2 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 6 inclusion and 9 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 12 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Low Enrollment). Results are not available in the source record.
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?
Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;. The study lists 2 primary outcomes in all. 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 12 Nov 2007.