Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058929
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2003-04-14
Brief Title:
A Transition Study From Flolan to Remodulin in Patients With Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Patients meeting all inclusionexclusion 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 inclusionexclusion 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 patients 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 investigators discretion
Patients meeting all inclusionexclusion 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 inclusionexclusion 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 patients 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 investigators 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 inclusionexclusion 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 inclusionexclusion criteria patients will be randomized to study drug 11 Remodulinplacebo 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 patients 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 patients 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 investigators discretion
Patients meeting all inclusionexclusion 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 inclusionexclusion criteria patients will be randomized to study drug 11 Remodulinplacebo 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 patients 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 patients 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 investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None