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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01389271
First received: June 27, 2011
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
 Drug: Ventavis inhaled (Iloprost, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389271

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Turkey
Recruiting
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01389271     History of Changes
Other Study ID Numbers: 14990, VE0910TR
Study First Received: June 27, 2011
Last Updated: May 19, 2013
Health Authority: Turkey: Ministry of Health General Driectorate of Pharmaceuticals and Pharmacy

Keywords provided by Bayer:
Pulmonary hypertension
Inhaled iloprost
Efficacy
Safety
 Tolerability
Survival
NYHA class III and IV

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

ClinicalTrials.gov processed this record on May 21, 2013