A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-011013-24-AT
• Date of registration: 30/04/2009
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd.
• Public title: A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension
• Scientific title: A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension
• Date of first enrolment: 03/06/2009
• Target sample size: 63
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011013-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other:

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
1.Signed informed consent prior to initiation of any study mandated procedure,

2.Patients with symptomatic idiopathic, familial pulmonary arterial hypertension or pulmonary hypertension associated with HIV or drugs/toxins (APAH) in NYHA functional class II to IV who have completed study AC-063A301,

3.Women of childbearing potential* with a negative urine pre-treatment pregnancy test 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% (oral hormonal contraceptive, implant, vaginal hormone ring, or intrauterine system [IUS]), during the entire study duration and for at least 1 month after last study drug intake. Their partner, if not vasectomised, must use a condom in addition.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,

2.Pulmonary arterial hypertension associated with significant venous or capillary involvement (PCWP > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,

3.HIV seropositive with any of the following:
•Active opportunistic infections within 3 months prior to randomization
•Changes in antiretroviral regimen within 3 months of randomization
•Using inhaled pentamidine

4.Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,

5.Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,

6.Pregnant or breast-feeding women,
7.Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),

8.Systolic blood pressure < 95 mmHg,

9.Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,

10.Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 µmol/L) or ongoing dialysis,

11.Clinically relevant bleeding disorder or active bleeding,

12.Known hypersensitivity to iloprost or any of its excipients.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Indication: Symptomatic Pulmonary Arterial Hypertension
MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension

Intervention(s)

Trade Name: Ventavis
Product Name: Iloprost
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Iloprost
CAS Number: 78919-13-8
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: -10

Primary Outcome(s)

Secondary Objective: To compare the inhalation times of inhaled iloprost delivered by I-neb using the power disc-15 or power disc-6 up to 12 weeks treatment in patients with symptomatic PAH.

Main Objective: To compare the safety and tolerability of inhaled iloprost delivered by power disc-15 or power disc-6 up to 12 weeks treatment in patients with symptomatic PAH.

Primary end point(s): •Treatment-emergent adverse events (AEs) from the first inhalation of study drug to the day before the end of 12-week treatment period or up to last inhalation in case of early discontinuation
•Treatment-emergent serious adverse events (SAEs) from the first inhalation of study drug to the day before the end of 12-week treatment period or up to last inhalation in case of early discontinuation
•AEs leading to premature discontinuation of study drug.

Secondary ID(s)

AC-063A302