Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

This study has been terminated.
(Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies)
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00439946
First received: February 22, 2007
Last updated: June 12, 2013
Last verified: June 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: treprostinil
Device: Crono Five ambulatory pump

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Treprostinil  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
    Treprostinil  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean ( Full Range )
  49.5  
  ( 45 to 59 )  
Gender  
[units: participants]
 
Female     8  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     8  
Pulmonary Arterial Hypertension (PAH) etiology  
[units: participants]
 
IPAH     6  
cardiovascular disease (CVD)     2  
Years since PAH diagnosis  
[units: years]
Mean ( Full Range )
  7  
  ( 1.5 to 12.9 )  
World Health Organization (WHO) functional class at time of transition [1]
[units: participants]
 
Class II     6  
Class III     2  
epoprostenol dose  
[units: ng/kg/min]
Mean ( Full Range )
  34.05  
  ( 7.7 to 71 )  
Baseline 6 Minute Walk Distance (6MWD) [2]
[units: meters]
Mean ( Full Range )
  390.5  
  ( 294 to 506 )  
[1] 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.
[2] This measure includes 6 patients. Two subjects did not have Baseline 6-Minute Walk Tests (6MWTs) conducted.



  Outcome Measures
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1.  Primary:   Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)   [ Time Frame: Week 8 ]

2.  Secondary:   Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test   [ Time Frame: Week 8 ]

3.  Secondary:   Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification   [ Time Frame: Week 8 ]

4.  Secondary:   Change From Baseline at Week 8 in Symptoms of PAH- Fatigue   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea   [ Time Frame: Week 8 ]

6.  Secondary:   Change From Baseline at Week 8 in Symptoms of PAH- Edema   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline at Week 8 in PAH Symptoms- Orthopnea   [ Time Frame: Week 8 ]

8.  Secondary:   Change From Baseline at Week 8 in PAH Symptoms- Dizziness   [ Time Frame: Week 8 ]

9.  Secondary:   Change From Baseline at Week 8 in PAH Symptoms- Syncope   [ Time Frame: Week 8 ]

10.  Secondary:   Change From Baseline at Week 8 in PAH Symptoms- Chest Pain   [ Time Frame: Week 8 ]

11.  Secondary:   Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol   [ Time Frame: Week 8 ]

12.  Secondary:   Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)   [ Time Frame: Baseline and Week 8 ]

13.  Secondary:   Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: Baseline and Week 8 ]

14.  Secondary:   Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitations of this study are the modest sample size and relatively short duration of follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Remodulin Program Leader
Organization: United Therapeutics
phone: (919) 485-8350
e-mail: ClinicalRecordsManagement@unither.com


No publications provided


Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00439946     History of Changes
Other Study ID Numbers: RIV-PH-410
Study First Received: February 22, 2007
Results First Received: March 26, 2013
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board