Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00709098
First received: July 1, 2008
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: iloprost
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Treatment-emergent Adverse Events [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ] [ Designated as safety issue: Yes ]
    Number of adverse events

  • Treatment-emergent Serious Adverse Events [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ] [ Designated as safety issue: Yes ]
    Number of serious adverse events

  • Adverse Events Leading to Premature Discontinuation of Study Drug [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ] [ Designated as safety issue: Yes ]
    Number of adverse events leading to discontinuation of study treatment

  • Patients With Adverse Events Leading to Premature Discontinuation of Study Drug [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events leading to discontinuation of study treatment


Other Outcome Measures:
  • Average Inhalation Time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)


Enrollment: 49
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iloprost power 6
iloprost power 15
Drug: iloprost
Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
Other Name: Ventavis
Experimental: iloprost power 15
iloprost power 15
Drug: iloprost
Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
Other Name: Ventavis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study mandated procedure,
  2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,
  3. 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:

  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 (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
  3. 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,
  4. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
  5. Pregnant or breast-feeding women,
  6. Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
  7. Systolic blood pressure < 95 mmHg,
  8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
  9. Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
  10. Clinically relevant bleeding disorder or active bleeding,
  11. Known hypersensitivity to iloprost or any of its excipients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709098

  Show 34 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Laila Rouault, MD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709098     History of Changes
Other Study ID Numbers: AC-063A302
Study First Received: July 1, 2008
Results First Received: September 27, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Ventavis
iloprost
inhaled treatment
inhalation solution
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014