Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years (OPTION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01389271
First received: June 27, 2011
Last updated: July 11, 2014
Last verified: July 2014

June 27, 2011
July 11, 2014
February 2011
May 2016   (final data collection date for primary outcome measure)
  • 6 Minutes walking distance (change in meters) [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
  • Adverse events, weight, vital findings [ Time Frame: At month 48 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01389271 on ClinicalTrials.gov Archive Site
  • 6 Minutes walking distance (% change) [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
  • New York Heart Association Functional Class [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
  • Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
  • Pulmonary hypertension related hospitalization [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
  • Heart and/or lung transplantation, mortality [ Time Frame: At month 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary (idiopathic and familial) pulmonary hypertension and PAH secondary to scleroderma without significant interstitial pulmonary disease classified as New York Heart Association (NYHA) functional class III and IV

Pulmonary Hypertension
Drug: Ventavis inhaled (Iloprost, BAYQ6256)
Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.
Group 1
Intervention: Drug: Ventavis inhaled (Iloprost, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
June 2017
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
  • Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
  • Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
  • Patients who signed written informed consent.

Exclusion Criteria:

  • Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
  • Severe arrhythmias;
  • Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
  • Pulmonary hypertension due to venous occlusive disease.
  • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
  • Pregnancy and lactation
  • Age below 18
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Turkey
 
NCT01389271
14990, VE0910TR
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2014

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