Iloprost Power Disc-15 in Pulmonary Arterial Hypertension (INHALE-15)

This study has been terminated.
(sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00723554
First received: July 24, 2008
Last updated: March 27, 2013
Last verified: March 2013

July 24, 2008
March 27, 2013
July 2008
August 2010   (final data collection date for primary outcome measure)
  • Number of Patients Reporting Treatment-emergent Adverse Events (AEs) [ Time Frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours ] [ Designated as safety issue: Yes ]
    Number of patients reporting at least one treatment-emergent AE/Serious AE
  • Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE [ Time Frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
  • Number of Patients Reporting Treatment-emergent Serious AEs [ Time Frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours ] [ Designated as safety issue: Yes ]
    Number of patients reporting at least one treatment-emergent serious AEs
  • Systolic Blood Pressure - Iloprost PD-6 (Period 1) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
  • Systolic Blood Pressure - Iloprost PD-15 (Period 2) [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
  • Systolic Blood Pressure - Iloprost PD-15 (Period 3) [ Time Frame: an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was measured at the end of study visit
  • Change in Systolic Blood Pressure - (Period 1 to Period 2) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
  • Change in Systolic Blood Pressure - (Period 1 to Period 3) [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
  • Diastolic Blood Pressure - Iloprost PD-6 (Period 1) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
  • Diastolic Blood Pressure - Iloprost PD-15 (Period 2) [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
  • Diastolic Blood Pressure - Iloprost PD-15 (Period 3) [ Time Frame: an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was measured at the end of study visit
  • Change in Diastolic Blood Pressure - (Period 1 to Period 2) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
  • Change in Diastolic Blood Pressure - (Period 1 to Period 3) [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
  • Heart Rate - Iloprost PD-6 (Period 1) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Heart rate was measured immediately prior to first dosing with Iloprost PD-15
  • Heart Rate - Iloprost PD-15 (Period 2) [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Heart rate was measured on Day 28 of treatment with Iloprost PD-15
  • Heart Rate - Iloprost PD-15 (Period 3) [ Time Frame: an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Heart rate was measured at the end of study visit
  • Change in Heart Rate - (Period 1 to Period 2) [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: Yes ]
    Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
  • Change in Heart Rate - (Period 1 to Period 3) [ Time Frame: Day 1 and End of study visit, an average of approximately 268 days ] [ Designated as safety issue: Yes ]
    Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Treatment-emergent adverse events (AEs) [ Time Frame: From the first dose of investigational product to the last dose of investigational product ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00723554 on ClinicalTrials.gov Archive Site
  • Average Inhalation Time - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Inhalation Time - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Inhalation Time - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Change in Average Inhalation Time - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Days of Dosing - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Days of Dosing - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Days of Dosing - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Change in Average Number of Days of Dosing - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Daily Doses - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Daily Doses - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Average Number of Daily Doses - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Change in Average Number of Daily Doses - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ] [ Designated as safety issue: No ]
    The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
  • New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]
    Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit)) [ Time Frame: average of approximately 268 days ] [ Designated as safety issue: No ]
    Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28) [ Time Frame: average approximately 28 days ] [ Designated as safety issue: No ]
    Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit) [ Time Frame: average approximately 268 days ] [ Designated as safety issue: No ]
    Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
  • Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]

    The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.

    On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit.

  • Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28) [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]

    The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.

    On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.

  • Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit)) [ Time Frame: average of approximately 268 days ] [ Designated as safety issue: No ]

    The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.

    On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.

  • Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28 [ Time Frame: average of approximately 28 days ] [ Designated as safety issue: No ]

    The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.

    On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.

  • Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit [ Time Frame: average of approximately 268 days ] [ Designated as safety issue: No ]

    The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.

    On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.

  • Adverse events leading to study discontinuation [ Time Frame: From the first dose of investigational product to study discontinuation ] [ Designated as safety issue: Yes ]
  • Treatment-emergent serious adverse events [ Time Frame: From the first dose of investigational product up to 48 hours after investigational product discontinuation ] [ Designated as safety issue: Yes ]
  • Changes in vital signs [ Time Frame: Between baseline and Day 28 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®

A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Iloprost PD-6
    Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
    Other Name: Ventavis
  • Drug: Iloprost PD-15

    Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.

    Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

    Other Name: Ventavis
Experimental: Iloprost

The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6.

The single-arm design allowed each patient to serve as his/her own control

Interventions:
  • Drug: Iloprost PD-6
  • Drug: Iloprost PD-15
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
63
April 2011
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent prior to initiation of any study-mandated procedure.
  • Male or female patients aged 18-85 years.
  • Patients with symptomatic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class III or IV at the time of initiation of iloprost inhalation (Ventavis®) therapy using the Power Disc-6 (PD-6).
  • Patients with the following types of pulmonary arterial hypertension (PAH) belonging to World Health Organization (WHO) Group I:

    • 1.1: Idiopathic (IPAH)
    • 1.2: Familial (FPAH)
    • 1.3: Associated with (APAH)

      • 1.3.1: Collagen vascular disease
      • 1.3.2: Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
      • 1.3.4: Human immunodeficiency virus (HIV) infection
      • 1.3.5: Drugs and toxins
  • PAH confirmed by the most recent right heart catheterization showing:

    • Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.
    • Pulmonary vascular resistance (PVR) > 240 dyn-sec/cm^5
  • Compliant with a treatment regimen of commercial iloprost inhalation (Ventavis® 5 μg) using the I-neb® AAD® equipped with the PD-6 for at least 4 weeks prior to screening.
  • Pulmonary function tests (PFTs) including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and total lung capacity (TLC), performed within 6 months of screening.
  • If taking other medications for PAH, these must have been stable for 60 days prior to baseline.
  • If taking corticosteroids, these must have been stable for 60 days prior to baseline.
  • Women of childbearing potential with a negative urine pre-treatment pregnancy test at baseline and who:

    • consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of < 1%,
    • are sexually abstinent, or
    • have a vasectomized partner.

A woman is considered to have childbearing potential unless she meets at least one of the following criteria:

  • Previous bilateral salpingo-oophorectomy or hysterectomy
  • Premature ovarian failure confirmed by a specialist gynecologist
  • XY genotype, Turner syndrome, uterine agenesis
  • Is aged > 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months

Exclusion Criteria:

  • PAH belonging to WHO group II-V.
  • PAH belonging to WHO group I other than that listed in the inclusion criteria, i.e., PAH associated with:

    • 1.3.3: Portal hypertension
    • 1.3.6: Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
    • 1.4: Associated with significant venous or capillary involvement:

      • 1.4.1: Pulmonary veno-occlusive disease (PVOD)
      • 1.4.2: Pulmonary capillary hemangiomatosis (PCH).
  • Receipt of any prostacyclin or prostacyclin analog other than iloprost within 12 weeks before screening.
  • Anticipation of the need for intravenous prostacyclin use within 28 days of starting the Power Disc-15 (PD-15).
  • HIV-seropositive with any of the following:

    • Concomitant active opportunistic infections within 6 months prior to screening
    • Detectable viral load within 6 months of screening
    • CD4+ T-cell count < 200 mm^3 within 3 months of screening
    • Changes in antiretroviral regimen within 3 months of screening
    • Anticipated changes in antiretroviral regimen during study periods 1 or 2
    • Using inhaled pentamidine
  • Systemic hypotension with systolic blood pressure < 95 mmHg.
  • Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement).
  • History of left-sided heart disease, including any of the following:

    • hemodynamically significant aortic or mitral valve disease
    • restrictive or congestive cardiomyopathy
    • left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
    • coronary artery disease with continuing symptoms of angina pectoris
    • life-threatening cardiac arrhythmias
  • Atrial septostomy within 1 year.
  • History of pulmonary embolism prior to diagnosis of PAH unless it can be documented that chronic thromboembolic pulmonary hypertension (CTEPH) has been specifically excluded (e.g., ventilation/perfusion (VQ) scan, pulmonary angiogram).
  • Restrictive lung disease: TLC < 60% of normal predicted value.
  • Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 or clinically relevant chronic obstructive lung disease or asthma (including any patient requiring concomitant medication to control symptoms of bronchospasm including as needed (p.r.n.) use).
  • Clinically relevant bleeding disorder or active bleeding.
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C or hepatic cirrhosis.
  • Pregnant or breast-feeding.
  • Chronic renal insufficiency, as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis.
  • Hemoglobin < 75% of the lower limit of normal range.
  • Any condition that prevents compliance with the protocol or adherence to therapy or ability to provide informed consent.
  • Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00723554
AC-063A402
No
Actelion
Actelion
Not Provided
Not Provided
Actelion
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP