Status:
TERMINATED
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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: Idiopathic (IPAH)
- 2: Familial (FPAH)
- 3: Associated with (APAH)
- 3.1: Collagen vascular disease
- 3.2: Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
- 3.4: Human immunodeficiency virus (HIV) infection
- 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
- 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:
- 3.3: Portal hypertension
- 3.6: Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
- 4: Associated with significant venous or capillary involvement:
- 4.1: Pulmonary veno-occlusive disease (PVOD)
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00723554
Start Date
July 1 2008
End Date
April 1 2011
Last Update
April 4 2013
Active Locations (36)
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1
University of South Alabama Medical
Mobile, Alabama, United States, 36617
2
Arizona Pulmonary Associates, Ltd.
Phoenix, Arizona, United States, 85013
3
Kaiser Foundation Hospital
Los Angeles, California, United States, 90027
4
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073