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Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643604
Recruitment Status : Terminated (Due to availability of eligible subjects at center and enrollment competition with other studies.)
First Posted : March 26, 2008
Results First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension, Pulmonary
Intervention Drug: treprostinil sodium
Enrollment 7
Recruitment Details The first subject was enrolled in March 2008. Given the limited availability of eligible subjects at the investigative center (stable PH patients on stable epoprostenol therapy) and competition for enrollment by other studies, after an extended recruitment period during which no new subjects were enrolled, the study was subsequently closed.
Pre-assignment Details  
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Period Title: Overall Study
Started 7
Completed 6
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
43.6
(32 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
5
  71.4%
Male
2
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
PAH etiology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
Idiopathic PAH 5
Collagen Vascular Disease 1
Portal Hypertension 1
World Health Organization (WHO) functional Class at time of transition   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
Class II 5
Class III 2
[1]
Measure Description: 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.
Baseline 6 Minute Walk Distance (6MWD)  
Mean (Full Range)
Unit of measure:  Meters
Number Analyzed 7 participants
466.6
(343 to 565)
1.Primary Outcome
Title Change in Six Minute Walk Distance
Hide Description [Not Specified]
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: meter
-14  (63.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
2.Secondary Outcome
Title Change in WHO Functional Classification
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No change 5
Worsened 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
3.Secondary Outcome
Title Change in Borg Dyspnea Score Immediately After Six Minute Walk
Hide Description 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).
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
4.Secondary Outcome
Title Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptom Score -2.5  (2.0)
Activitity Score -0.8  (2.6)
Quality of Life Score -4.4  (6.7)
Total Score -8.0  (8.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments p value for Symptom Score
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments p value for Activity Score.
Method Wilcoxon signed rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments

Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.

Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
5.Secondary Outcome
Title Change in Score on Treatment Satisfaction Questionnaire for Medication
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Effectiveness Score -9.3  (13.0)
Side-Effects Score 19.8  (28.9)
Convenience Score 22.2  (12.2)
Global Satisfaction Score -1.2  (21.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
6.Secondary Outcome
Title Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Hide Description 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
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

Two subjects did not have Week 8 Drug Administration Activity Diaries completed.

Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject.

Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: minutes
Gather/Set-up -2.6  (4.0)
Prepare Drug -39.4  (12.8)
Connect Drug -5.0  (11.3)
Change Dressing 0.0  (10.6)
Total Time -44.0  (25.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
7.Secondary Outcome
Title Change in PAH Signs and Symptoms- Fatigue
Hide Description The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 4
Worsened 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
8.Secondary Outcome
Title Change From in Signs and Symptoms of PAH- Edema
Hide Description The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 3
Worsened 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon sign-rank test
Comments [Not Specified]
9.Secondary Outcome
Title Change in Signs and Symptoms of PAH- Dyspnea
Hide Description The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 1
No Change 3
Worsened 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
10.Secondary Outcome
Title Change in Signs and Symptoms of PAH- Orthopnea
Hide Description The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 4
Worsened 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
11.Secondary Outcome
Title Change in Signs and Symptoms of PAH- Dizziness
Hide Description The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 5
Worsened 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
12.Secondary Outcome
Title Change in Signs and Symptoms of PAH- Syncope
Hide Description The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 6
Worsened 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
13.Secondary Outcome
Title Change in Signs and Symptoms of PAH- Chest Pain
Hide Description The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Improved 0
No Change 5
Worsened 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treprostinil Sodium
Comments Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
14.Secondary Outcome
Title Patient Impression of Change Questionnaire
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description:
treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Symptoms- Much Better 0
Symptoms-Somewhat Better 2
Symptoms- About the Same 3
Symptoms- Somewhat Worse 1
Symptoms-Much Worse 0
Time Spent- Much Less 3
Time Spent- Somewhat Less 3
Time Spent- About the Same 0
Time Spent- Somewhat More 0
Time Spent- Much More 0
Satisfaction- Much More Satisfied 1
Satisfaction- More Satisfied 3
Satisfaction- About the Same 1
Satisfaction- Less Satisfied 1
Satisfaction- Much Less Satisfied 0
Time Frame Adverse events were assessed upon initiation of Remodulin through to the end of study (Week 8)
Adverse Event Reporting Description Since subjects were transitioning from an existing prostacyclin therapy, prostacylin-class side effects ongoing at Baseline prior to transition were recorded separately on the specific Prostacyclin Side Effects Questionnaire. Events which increased in severity from Baseline were captured and reported as AEs.
 
Arm/Group Title Treprostinil Sodium
Hide Arm/Group Description treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
All-Cause Mortality
Treprostinil Sodium
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treprostinil Sodium
Affected / at Risk (%) # Events
Total   2/7 (28.57%)    
Gastrointestinal disorders   
Abdominal pain * 1 [1]  1/7 (14.29%)  1
Nausea * 1 [1]  1/7 (14.29%)  1
Vomiting * 1 [1]  1/7 (14.29%)  1
Infections and infestations   
Bacteraemia * 1 [2]  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Dehydration * 1 [1]  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
Subject was hospitalized for abdominal pain, nausea, vomiting and dehydration and subsequently died. The investigator assessed the relationship to the study drug as not reasonably attributable to the study drug.
[2]
One subject was hospitalized for bacteraemia attributed to Remodulin.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treprostinil Sodium
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Gastrointestinal disorders   
Nausea * 1  3/7 (42.86%)  3
Vomiting * 1  3/7 (42.86%)  3
Diarrhoea * 1  3/7 (42.86%)  4
General disorders   
Pyrexia * 1  1/7 (14.29%)  1
Infusion site reaction * 1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Pain in Extremity * 1  3/7 (42.86%)  3
Arthralgia * 1  1/7 (14.29%)  1
Back Pain * 1  1/7 (14.29%)  1
Pain in Jaw * 1  1/7 (14.29%)  1
Nervous system disorders   
Headache * 1  5/7 (71.43%)  6
Dizziness * 1  1/7 (14.29%)  1
Sinus headache * 1  1/7 (14.29%)  1
Tremor * 1  1/7 (14.29%)  1
Psychiatric disorders   
Anxiety * 1  2/7 (28.57%)  2
Insomnia * 1  2/7 (28.57%)  2
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/7 (14.29%)  1
Dyspnoea * 1  1/7 (14.29%)  1
Vascular disorders   
Flushing * 1  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
The main limitations of this study are the small sample size, open-label design and relatively short duration of follow-up.
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.

There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the Principal Investigator's rights to discuss or publish trial results after the trial is completed.

Any publication of the results of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the Investigator contract.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Remodulin Program Leader
Organization: United Therapeutics Corporation
Phone: 919-485-8350
EMail: clinicalrecordsmanagement@unither.com
Layout table for additonal information
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00643604    
Other Study ID Numbers: RIV-PH-413
First Submitted: March 20, 2008
First Posted: March 26, 2008
Results First Submitted: March 28, 2013
Results First Posted: June 21, 2013
Last Update Posted: June 21, 2013