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Trial record 31 of 61 for:    "Lung Disease" | "Iloprost"

The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension (VISION)

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: NCT00302211
Recruitment Status : Terminated (Terminated due to slow enrollment)
First Posted : March 14, 2006
Results First Posted : August 13, 2010
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Interventions Drug: Inhaled Iloprost (5 μg)
Drug: Inhaled Placebo
Drug: Sildenafil
Drug: Bosentan
Enrollment 67
Recruitment Details Due to slow participant enrollment, the study was prematurely terminated, and recruitment was stopped after 67 subjects had been recruited instead of 180 initially planned (37% of the originally-planned sample size)
Pre-assignment Details  
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Inhaled Iloprost 4x/Day
Hide Arm/Group Description Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan Inhaled placebo 6×/day plus sildenafil with or without bosentan The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period Subjects in this group received inhaled iloprost (5μg) 4x/day plus sildenafil with or without bosentan during the open-label period
Period Title: Double Blind Period (New Patients)
Started 26 [1] 27 [1] 14 [2] 0 0
Completed 23 25 10 0 0
Not Completed 3 2 4 0 0
Reason Not Completed
Withdrawal by Subject             2             1             0             0             0
Adverse Event             0             0             3             0             0
Investigator's judgement             1             0             0             0             0
Disease progression             0             1             1             0             0
[1]
These subjects had the option to continue with the same dose of iloprost during the OL period
[2]
These subjects could receive either iloprost 4x/day or 6x/day in the OL period
Period Title: Open Label-Patients From Double-Blind
Started 0 0 0 26 [1] 32 [2]
Completed 0 0 0 18 24
Not Completed 0 0 0 8 8
Reason Not Completed
Withdrawal by Subject             0             0             0             3             3
Adverse Event             0             0             0             1             0
Investigator's judgement             0             0             0             1             0
Disease progression             0             0             0             1             2
Death             0             0             0             1             1
Lost to Follow-up             0             0             0             0             1
PH requiring lung transplant             0             0             0             0             1
Termination of the study by the sponsor             0             0             0             1             0
[1]
21 patients (pts) in 6x/day DB phase & 5 patients in placebo 6x/day DB phase enrolled in OL 6x/day
[2]
26 pts in 4x/day + placebo 2x/day DB phase & 6 pts in placebo 6x/day DB phase enrolled in OL 4x/day
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day Total
Hide Arm/Group Description Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan Inhaled placebo 6×/day plus sildenafil with or without bosentan Total of all reporting groups
Overall Number of Baseline Participants 26 27 14 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 14 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  88.5%
17
  63.0%
9
  64.3%
49
  73.1%
>=65 years
3
  11.5%
10
  37.0%
5
  35.7%
18
  26.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 14 participants 67 participants
51.9  (11.95) 56.6  (16.27) 56.9  (11.90) 54.8  (13.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 14 participants 67 participants
Female
20
  76.9%
19
  70.4%
13
  92.9%
52
  77.6%
Male
6
  23.1%
8
  29.6%
1
   7.1%
15
  22.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 14 participants 67 participants
United States
14
  53.8%
15
  55.6%
9
  64.3%
38
  56.7%
United Kingdom
4
  15.4%
2
   7.4%
1
   7.1%
7
  10.4%
Spain
0
   0.0%
1
   3.7%
1
   7.1%
2
   3.0%
Italy
0
   0.0%
1
   3.7%
0
   0.0%
1
   1.5%
Germany
7
  26.9%
6
  22.2%
3
  21.4%
16
  23.9%
Austria
1
   3.8%
2
   7.4%
0
   0.0%
3
   4.5%
1.Primary Outcome
Title Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
Hide Description The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
Time Frame Day 1 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day
Hide Arm/Group Description:
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Inhaled placebo 6×/day plus sildenafil with or without bosentan
Overall Number of Participants Analyzed 26 27 13
Mean (Standard Deviation)
Unit of Measure: Meters
10.1  (62.15) 29.6  (55.17) -22.0  (124.7)
2.Secondary Outcome
Title Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
Hide Description This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Time Frame Day 1 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day
Hide Arm/Group Description:
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Inhaled placebo 6×/day plus sildenafil with or without bosentan
Overall Number of Participants Analyzed 26 27 13
Measure Type: Count of Participants
Unit of Measure: Participants
4
  15.4%
6
  22.2%
0
   0.0%
3.Secondary Outcome
Title Time to Clinical Worsening
Hide Description Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported.
Time Frame Week 16 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who received at least one dose of study drug and with available data at Week 16 (for the double-blind period) and at Week 48 (for the open-label period) were included in the analysis
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Hide Arm/Group Description:
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Inhaled placebo 6×/day plus sildenafil with or without bosentan
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
Overall Number of Participants Analyzed 26 27 14 22 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   3.7%
1
   7.1%
2
   9.1%
3
  10.7%
4.Other Pre-specified Outcome
Title Number of Participants With Any Adverse Events
Hide Description This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit.
Time Frame From Day 1 to Week 16 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All randomiized subjects who received at least one dose of the study drug
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Hide Arm/Group Description:
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Inhaled placebo 6×/day plus sildenafil with or without bosentan
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
Overall Number of Participants Analyzed 26 27 14 26 32
Measure Type: Count of Participants
Unit of Measure: Participants
24
  92.3%
22
  81.5%
14
 100.0%
23
  88.5%
30
  93.8%
5.Post-Hoc Outcome
Title Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period
Hide Description The number of participants in the double-blind treatment period who showed improvement or worsening in the 6-MWT - from baseline distance between 100-450 meters - was assessed for each treatment group. The 6-minute walks were measured in meters. Any increase in walk distance at Week 16 was considered improvement from baseline, any decrease was considered as deterioration from baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had a post-baseline efficacy measure at Week 16.
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day
Hide Arm/Group Description:
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
Inhaled placebo 6×/day plus sildenafil with or without bosentan
Overall Number of Participants Analyzed 26 27 13
Measure Type: Count of Participants
Unit of Measure: Participants
6-MWT improvement
13
  50.0%
18
  66.7%
9
  69.2%
6-MWT deterioration
12
  46.2%
8
  29.6%
4
  30.8%
No change
1
   3.8%
1
   3.7%
0
   0.0%
Time Frame from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Adverse Event Reporting Description Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
 
Arm/Group Title DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Hide Arm/Group Description Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan Inhaled placebo 6×/day plus sildenafil with or without bosentan The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
All-Cause Mortality
DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/26 (11.54%)   5/27 (18.52%)   3/14 (21.43%)   4/26 (15.38%)   13/32 (40.63%) 
Blood and lymphatic system disorders           
Anemia * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Cardiac disorders           
Atrial fibrillation * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Right ventricular failure * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Atrial flutter * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Cardiac failure * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Sick sinus syndrome * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Gastrointestinal disorders           
Inguinal hernia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
General disorders           
Chest pain * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Infections and infestations           
Cellulitis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gastroenteritis viral * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Pneumonia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  1/26 (3.85%)  1/32 (3.13%) 
Herpes zoster * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Pneumococcal sepsis * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Sepsis * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Injury, poisoning and procedural complications           
Subdural hematoma * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Wrist fracture * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Metabolism and nutrition disorders           
Fluid overload * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  2/32 (6.25%) 
Dehydration * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Multiple myeloma * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Nervous system disorders           
Presyncope * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Syncope * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders           
Epistaxis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Pulmonary hypertension * 1  0/26 (0.00%)  1/27 (3.70%)  2/14 (14.29%)  1/26 (3.85%)  3/32 (9.38%) 
Vascular disorders           
Lupus vasculitis * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
DB Iloprost 6×/Day DB Iloprost 4×/Day DB Placebo 6×/Day OL Iloprost 6x/Day OL Iloprost 4x/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/26 (92.31%)   22/27 (81.48%)   14/14 (100.00%)   23/26 (88.46%)   30/32 (93.75%) 
Cardiac disorders           
Arrhythmia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Atrial Fibrillation * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Atrial flutter * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Cardiac failure * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Palpitations * 1  3/26 (11.54%)  0/27 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  0/32 (0.00%) 
Right ventricular failure * 1  1/26 (3.85%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Supraventricular extrasystoles * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Tachycardia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Ventricular arrhythmia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Ventricular extrasystoles * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Ear and labyrinth disorders           
Ear pain * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Middle ear effusion * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Vertigo * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Eye disorders           
Conjunctivitis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Abdominal pain upper * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Constipation * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Diarrhoea * 1  2/26 (7.69%)  1/27 (3.70%)  1/14 (7.14%)  0/26 (0.00%)  2/32 (6.25%) 
Dry mouth * 1  2/26 (7.69%)  1/27 (3.70%)  0/14 (0.00%)  3/26 (11.54%)  1/32 (3.13%) 
Dysphagia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Glossodynia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Inguinal hernia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Mouth ulceration * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Nausea * 1  2/26 (7.69%)  2/27 (7.41%)  1/14 (7.14%)  1/26 (3.85%)  0/32 (0.00%) 
Oesophagitis * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Abdominal distension * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Vomiting * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
General disorders           
Asthenia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Chest discomfort * 1  4/26 (15.38%)  1/27 (3.70%)  1/14 (7.14%)  2/26 (7.69%)  1/32 (3.13%) 
Chest pain * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Chills * 1  2/26 (7.69%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Fatigue * 1  2/26 (7.69%)  1/27 (3.70%)  1/14 (7.14%)  1/26 (3.85%)  1/32 (3.13%) 
Oedema * 1  1/26 (3.85%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Oedema peripheral * 1  1/26 (3.85%)  3/27 (11.11%)  0/14 (0.00%)  1/26 (3.85%)  1/32 (3.13%) 
Swelling * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Infections and infestations           
Bronchitis * 1  0/26 (0.00%)  2/27 (7.41%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Cellulitis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gastroenteritis rotavirus * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gastroenteritis viral * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Herpes zoster * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Infection * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Influenza * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Lymph gland infection * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Mastitis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Nasopharyngitis * 1  4/26 (15.38%)  2/27 (7.41%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Oral candidiasis * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Oral herpes * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Pharyngitis * 1  1/26 (3.85%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Pneumonia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Rash pustular * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Rhinitis * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Sinusitis * 1  3/26 (11.54%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Staphylococcal infection * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Tooth abscess * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Upper respiratory tract infection * 1  2/26 (7.69%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Viral infection * 1  1/26 (3.85%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Ear infection * 1  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Injury, poisoning and procedural complications           
Contusion * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Head injury * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Laceration * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Fluid overload * 1  1/26 (3.85%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Fluid retention * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gout * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Hyperkalaemia * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Back pain * 1  3/26 (11.54%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Intervertebral disc protrusion * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Limb discomfort * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Musculoskeletal pain * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  1/32 (3.13%) 
Myalgia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Osteoarthritis * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Pain in extremity * 1  0/26 (0.00%)  1/27 (3.70%)  1/14 (7.14%)  0/26 (0.00%)  1/32 (3.13%) 
Pain in jaw * 1  2/26 (7.69%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Sensation of heaviness * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Multiple myeloma * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Nasal sinus cancer * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Nervous system disorders           
Burning sensation * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Dizziness * 1  4/26 (15.38%)  0/27 (0.00%)  3/14 (21.43%)  5/26 (19.23%)  1/32 (3.13%) 
Headache * 1  10/26 (38.46%)  7/27 (25.93%)  2/14 (14.29%)  10/26 (38.46%)  6/32 (18.75%) 
Hypogeusia * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Presyncope * 1  1/26 (3.85%)  2/27 (7.41%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Somnolence * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Syncope * 1  2/26 (7.69%)  3/27 (11.11%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Psychiatric disorders           
Anxiety * 1  2/26 (7.69%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Depression * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Dyssomnia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Insomnia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Nervousness * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Dysuria * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Reproductive system and breast disorders           
Erectile dysfunction * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Gynaecomastia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Penile oedema * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  6/26 (23.08%)  8/27 (29.63%)  2/14 (14.29%)  4/26 (15.38%)  2/32 (6.25%) 
Dry throat * 1  3/26 (11.54%)  0/27 (0.00%)  0/14 (0.00%)  2/26 (7.69%)  0/32 (0.00%) 
Dysphonia * 1  2/26 (7.69%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Dyspnoea * 1  2/26 (7.69%)  0/27 (0.00%)  1/14 (7.14%)  1/26 (3.85%)  0/32 (0.00%) 
Epistaxis * 1  2/26 (7.69%)  2/27 (7.41%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Hypoxia * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Nasal congestion * 1  2/26 (7.69%)  1/27 (3.70%)  1/14 (7.14%)  0/26 (0.00%)  1/32 (3.13%) 
Nasal dryness * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Paranasal sinus hypersecretion * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Pharyngolaryngeal pain * 1  1/26 (3.85%)  1/27 (3.70%)  0/14 (0.00%)  4/26 (15.38%)  1/32 (3.13%) 
Productive cough * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/26 (3.85%)  0/32 (0.00%) 
Pulmonary hypertension * 1  0/26 (0.00%)  1/27 (3.70%)  3/14 (21.43%)  0/26 (0.00%)  0/32 (0.00%) 
Sleep apnoea syndrome * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Throat irritation * 1  4/26 (15.38%)  0/27 (0.00%)  1/14 (7.14%)  1/26 (3.85%)  1/32 (3.13%) 
Throat tightness * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Wheezing * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders           
Hyperkeratosis * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Periorbital oedema * 1  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/26 (0.00%)  0/32 (0.00%) 
Pruritus * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Rash * 1  0/26 (0.00%)  2/27 (7.41%)  0/14 (0.00%)  0/26 (0.00%)  1/32 (3.13%) 
Swelling face * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Surgical and medical procedures           
Inguinal hernia * 1  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Medical device implantation * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Vascular disorders           
Cardiovascular insufficiency * 1  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  0/26 (0.00%)  0/32 (0.00%) 
Flushing * 1  6/26 (23.08%)  3/27 (11.11%)  1/14 (7.14%)  6/26 (23.08%)  4/32 (12.50%) 
Hypotension * 1  3/26 (11.54%)  4/27 (14.81%)  1/14 (7.14%)  0/26 (0.00%)  2/32 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Primary purpose was to evaluate the efficacy of iloprost in PAH patients. Due to slow recruitment only 67 of the 180 participants planned were enrolled. Consequently efficacy results are not meaningful and no statistical analyses could be performed.
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.
Written permission to publish results must be obtained in advance from Actelion (formerly CoTherix). Manuscript of any proposed publication must be sent to Actelion at least 30 days in advance of the submission date. Actelion will inform in writing of any objection of specific content in the proposed publication.In addition, the institution shall either delete disclosure of all potentially patentable inventions or delay submission of the proposed publication for up to 90 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Palmer SVP, US Medical Affairs
Organization: Actelion Pharmaceuticals US, Inc.
Phone: 650-624-6900
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00302211     History of Changes
Other Study ID Numbers: C200-006
First Submitted: March 10, 2006
First Posted: March 14, 2006
Results First Submitted: May 27, 2010
Results First Posted: August 13, 2010
Last Update Posted: April 16, 2019