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TerminatedNCT00467896Updated Apr 4, 2013Results posted

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

A Phase 2 interventional study of Iloprost PD-6 and Iloprost PD-15 in Pulmonary Hypertension, sponsored by Actelion. Terminated at 12 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-04-04.

Sponsored by Actelion · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor's decision
Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • PAH
  • iloprost
  • Ventavis
  • Pulmonary Arterial Hypertension
  • Actelion Pharmaceuticals
  • Cotherix
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 62 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female, aged 18-85 years
  • Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
  • On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6

Exclusion criteria

Exclusion Criteria:

  • Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
  • Receipt of atrial septostomy within the 6 months preceding Screening
  • History of left-sided heart disease
  • Clinically relevant obstructive lung disease
  • Chronic renal or liver disease
  • Uncontrolled systemic hypertension or hypotension
  • Cerebrovascular event within the 6 months preceding Screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Iloprost

    The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.

    Drug: Iloprost PD-6 · Drug: Iloprost PD-15

Interventions

  • DrugIloprost PD-6

    Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.

    Also known as: Ventavis

  • DrugIloprost PD-15

    Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.

    Also known as: Ventavis

06

What researchers measure

Primary outcomes

  1. Inhalation-times Rate - Iloprost PD-6 (Period I)

    Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15

  2. Inhalation-times Rate - Iloprost PD-15 (Period II)

    Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days following first dose of iloprost PD-15

  3. Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)

    Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15

Secondary outcomes

  1. Number of Daily Inhalations - Iloprost PD-6 (Period I)

    Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15

  2. Number of Daily Inhalations - Iloprost PD-15 (Period II)

    Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days following first dose of iloprost PD-15

  3. Daily Inhalation Duration - Iloprost PD-6 (Period I)

    Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15

  4. Daily Inhalation Duration - Iloprost PD-15 (Period II)

    Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days following first dose of iloprost PD-15

  5. Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)

    The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15

  6. Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)

    The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days following first dose of iloprost PD-15

  7. Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)

    The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days prior to first dose of iloprost PD-15

  8. Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)

    The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

    Time frame: 37 days following first dose of iloprost PD-15

  9. Systolic Blood Pressure - Iloprost PD-6 (Period I)

    SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

    Time frame: Day 1, prior to first dose of iloprost PD-15

  10. Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)

    SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

    Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15

  11. Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)

    DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

    Time frame: Day 1, prior to first dose of iloprost PD-15

  12. Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)

    DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

    Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15

  13. Heart Rate (HR) - Iloprost PD-6 (Period I)

    HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

    Time frame: Day 1, prior to first dose of iloprost PD-15

  14. Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)

    HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

    Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15

07

Results

Posted Oct 26, 2012
Limitations and caveats
Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.

Participant flow

Patients were enrolled across 12 U.S. centers.

Participant flow — Overall Study
MilestoneIloprost
Started62
Completed11
Not completed51
Withdrew: Consent withdrawal18
Withdrew: Adverse event7
Withdrew: Serious adverse event13
Withdrew: Non-compliance3
Withdrew: Changed therapy2
Withdrew: Patient received transplant2
Withdrew: Patient had atrial septostomy1
Withdrew: Patient weaned off iloprost1
Withdrew: Mainly used prodose not i-neb® device1
Withdrew: Started intravenous prostacyclin1
Withdrew: Started inhaled remodulin1
Withdrew: Patient had no improvement1

Outcome measures

PrimaryInhalation-times Rate - Iloprost PD-6 (Period I)

Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15
Reported as:
Mean · percentage of full doses administered
Inhalation-times Rate - Iloprost PD-6 (Period I)
percentage of full doses administeredIloprost PD-6
Inhalation-times Rate - Iloprost PD-6 (Period I)29.9 ± 28.75
SecondaryNumber of Daily Inhalations - Iloprost PD-6 (Period I)

Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15
Reported as:
Mean · inhalations/day
Number of Daily Inhalations - Iloprost PD-6 (Period I)
inhalations/dayIloprost PD-6
Number of Daily Inhalations - Iloprost PD-6 (Period I)5.8 ± 1.22
SecondaryNumber of Daily Inhalations - Iloprost PD-15 (Period II)

Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days following first dose of iloprost PD-15
Reported as:
Mean · inhalations/day
Number of Daily Inhalations - Iloprost PD-15 (Period II)
inhalations/dayIloprost PD-15
Number of Daily Inhalations - Iloprost PD-15 (Period II)6.0 ± 1.11
SecondaryDaily Inhalation Duration - Iloprost PD-6 (Period I)

Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15
Reported as:
Mean · minutes
Daily Inhalation Duration - Iloprost PD-6 (Period I)
minutesIloprost PD-6
Daily Inhalation Duration - Iloprost PD-6 (Period I)15.0 ± 5.48
SecondaryDaily Inhalation Duration - Iloprost PD-15 (Period II)

Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days following first dose of iloprost PD-15
Reported as:
Mean · minutes
Daily Inhalation Duration - Iloprost PD-15 (Period II)
minutesIloprost PD-15
Daily Inhalation Duration - Iloprost PD-15 (Period II)7.2 ± 2.17
SecondaryPercentage of Complete Doses Administered - Iloprost PD-6 (Period I)

The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15
Reported as:
Mean · percentage of complete doses
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
percentage of complete dosesIloprost PD-6
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)83.1 ± 21.18
SecondaryPercentage of Complete Doses Administered - Iloprost PD-15 (Period II)

The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days following first dose of iloprost PD-15
Reported as:
Mean · percentage of complete doses
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
percentage of complete dosesIloprost PD-15
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)98.0 ± 3.42
SecondaryPercentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)

The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15
Reported as:
Mean · percentage of daily doses
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
percentage of daily dosesIloprost PD-6
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)55.1 ± 29.53
PrimaryInhalation-times Rate - Iloprost PD-15 (Period II)

Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days following first dose of iloprost PD-15
Reported as:
Mean · percentage of full doses administered
Inhalation-times Rate - Iloprost PD-15 (Period II)
percentage of full doses administeredIloprost PD-15
Inhalation-times Rate - Iloprost PD-15 (Period II)79.7 ± 17.45
SecondaryPercentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)

The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days following first dose of iloprost PD-15
Reported as:
Mean · percentage of daily doses
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
percentage of daily dosesIloprost PD-15
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)66.1 ± 21.2
SecondarySystolic Blood Pressure - Iloprost PD-6 (Period I)

SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

Time frame:
Day 1, prior to first dose of iloprost PD-15
Reported as:
Mean · mmHg
Systolic Blood Pressure - Iloprost PD-6 (Period I)
mmHgIloprost PD-6
pre-dose114.1 ± 11.68
immediately post-dose110.8 ± 11.47
15 minutes post dose113.0 ± 13.45
SecondarySystolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)

SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

Time frame:
Day 1 and Day 7, following the first dose of iloprost PD-15
Reported as:
Mean · mmHg
Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
mmHgIloprost PD-15
pre-dose (Day 1)114.5 ± 14.99
immediately post-dose (Day 1)111.7 ± 14.39
15 minutes post-dose (Day 1)113.9 ± 14.76
pre-dose (Day 7)114.7 ± 16.14
immediately post-dose (Day 7)109.7 ± 15.76
15 minutes post-dose (Day 7)113.1 ± 15.39
SecondaryDiastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)

DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

Time frame:
Day 1, prior to first dose of iloprost PD-15
Reported as:
Mean · mmHg
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
mmHgIloprost PD-6
pre-dose68.6 ± 10.94
immediately post-dose65.6 ± 8.98
15 minutes post-dose66.6 ± 9.79
SecondaryDiastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)

DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

Time frame:
Day 1 and Day 7, following the first dose of iloprost PD-15
Reported as:
Mean · mmHg
Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
mmHgIloprost PD-15
pre-dose (Day 1)67.5 ± 10.44
immediately post-dose (Day 1)65.2 ± 8.72
15 minutes post-dose (Day 1)67.9 ± 11.16
pre-dose (Day 7)68.6 ± 11.22
immediately post-dose (Day 7)65.7 ± 11.34
15 minutes post-dose (Day 7)66.7 ± 11.52
SecondaryHeart Rate (HR) - Iloprost PD-6 (Period I)

HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6

Time frame:
Day 1, prior to first dose of iloprost PD-15
Reported as:
Mean · beats per minute
Heart Rate (HR) - Iloprost PD-6 (Period I)
beats per minuteIloprost PD-6
pre-dose79.2 ± 13.14
immediately post-dose78.9 ± 13.39
15 minutes post-dose76.1 ± 13.25
SecondaryHeart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)

HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15

Time frame:
Day 1 and Day 7, following the first dose of iloprost PD-15
Reported as:
Mean · beats per minute
Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
beats per minuteIloprost PD-15
pre-dose (Day 1)78.0 ± 13.02
immediately post-dose (Day 1)77.9 ± 12.90
15 minutes post-dose (Day 1)76.4 ± 12.31
pre-dose (Day 7)77.8 ± 12.31
immediately post-dose (Day 7)78.3 ± 12.45
15 minutes post-dose (Day 7)76.0 ± 12.51
PrimaryChange in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)

Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)

Time frame:
37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
Reported as:
Mean · percentage of full doses administered
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
percentage of full doses administeredIloprost PD-15
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)49.8 ± 34.28
Statistical analysis
  • Iloprost PD-15 · t-test, 2 sided · p = <0.0001 · Mean difference (net): 49.8 · 95% CI 39.55 to 60.15

Adverse events

Collected over Adverse events were collected from baseline visit to end of study visit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Iloprost PD-15—27/62 (43.5%)53/62 (85.5%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventIloprost PD-15
Pulmonary Arterial HypertensionRespiratory, thoracic and mediastinal disorders10/62
SyncopeNervous system disorders4/62
Pulmonary HypertensionRespiratory, thoracic and mediastinal disorders3/62
Right Ventricular FailureCardiac disorders3/62
Cardiac FailureCardiac disorders2/62
AnaemiaBlood and lymphatic system disorders2/62
Fluid OverloadMetabolism and nutrition disorders2/62
Renal FailureRenal and urinary disorders2/62
Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders1/62
DyspnoeaRespiratory, thoracic and mediastinal disorders1/62
Most frequent other events
Showing 10 of 31
Most frequent other events
EventIloprost PD-15
Pulmonary Arterial HypertensionRespiratory, thoracic and mediastinal disorders18/62
DyspnoeaRespiratory, thoracic and mediastinal disorders13/62
FatigueGeneral disorders13/62
NauseaGastrointestinal disorders11/62
CoughRespiratory, thoracic and mediastinal disorders9/62
Pulmonary HypertensionRespiratory, thoracic and mediastinal disorders9/62
HypokalaemiaMetabolism and nutrition disorders9/62
SinusitisInfections and infestations8/62
HeadacheNervous system disorders7/62
Upper Respiratory Tract InfectionInfections and infestations7/62

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Iloprost
<=18 years1
Between 18 and 65 years43
>=65 years18
Age Continuous
Age Continuous(years)Iloprost
Mean52.5 ± 14.87
Sex: Female, Male
Sex: Female, Male(Participants)Iloprost
Female46
Male16
Region of Enrollment
Region of Enrollment(participants)Iloprost
United States62
08

Study locations

12 sites
  • Pulmonary Associates
    Phoenix, Arizona 85006, United States
  • UCSD Medical Center, Thorton Hospital
    La Jolla, California 92037, United States
  • University of Iowa Hospital and Clinics
    Iowa City, Iowa 52242, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70112, United States
  • University of Maryland Hospital
    Baltimore, Maryland 21201, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • New York Presbyterian Hospital
    New York, New York 10032, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Diagnostic Research Group
    San Antonio, Texas 78229, United States
  • Aurora Medical Group - Cardiovascular Services
    Milwaukee, Wisconsin 53215, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00467896
Lead sponsor
Actelion
Responsible party
Sponsor
First posted
May 1, 2007
Start date
Sep 2006
Primary completion
Nov 2010
Completion
Jun 2011
Results posted
Oct 26, 2012
Last update
Apr 4, 2013

Study contacts

Michael A Mathier, MD
principal investigator · University of Pittsburgh Medical Center
Ramagopal Tumuluri, MD
principal investigator · Aurora Medical Group - Cardiovascular Services
Charles J. Burch, MD
principal investigator · Diagnostic Research Group
David Baratz, MD
principal investigator · Pulmonary Associates
Ben DeBoisblanc, MD
principal investigator · Ochsner Health System
Adaani Frost, MD
principal investigator · Baylor College of Medicine
Victor Test, MD
principal investigator · UCSD Medical Center, Thorton Hospital
Sif Handsdottir, MD
principal investigator · University of Iowa Hospital & Clinics
Myung Park, MD
principal investigator · University of Maryland Hospital
Evelyn Horn, MD
principal investigator · New York Presbyterian Hospital
Erika Berman-Rosenzweig, MD
principal investigator · Columbia University
Victor Tapson, MD
principal investigator · Duke University
View the source record on ClinicalTrials.gov ↗

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