Iloprost Power 15 in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00709956
• Date of registration: 01/07/2008
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Iloprost Power 15 in Pulmonary Arterial Hypertension PROWESS 15
• Scientific title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension
• Date of first enrolment: July 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00709956
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, Germany, United States

Contacts

• Name: Laila Rouault, MD
• Affiliation: Actelion

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent prior to initiation of any study mandated procedure,

- Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or
pulmonary hypertension associated with human immunodeficiency virus (HIV) or
drugs/toxins in NYHA functional class II to IV.

- Women of childbearing potential must have a negative urine pregnancy test and must use
an adequate method of contraception during the study and for 28 days after
discontinuation of the study drug.

Exclusion Criteria:

- Pulmonary arterial hypertension related to any condition other than those specified in
the inclusion criteria,

- Pulmonary arterial hypertension associated with significant venous or capillary
involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg),

- Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,

- 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,

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

- Pregnant or breast-feeding women,

- Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure
> 100 mmHg on repeated measurement),

- Systolic blood pressure < 95 mmHg,

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

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

- Clinically relevant bleeding disorder or active bleeding,

- For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or
sildenafil, according to product label,

- Known hypersensitivity to iloprost or any of its excipients.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: iloprost (5 µg)

Drug: placebo

Primary Outcome(s)

6-minute-walk Distance (6MWD) [Time Frame: Study day 2 or study day 3]

Secondary Outcome(s)

Borg Dyspnea Score [Time Frame: Study day 2 or study day 3]

Secondary ID(s)

AC-063A301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00709956