NCT00414687

Brief Summary

The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 1998

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

First QC Date

December 20, 2006

Last Update Submit

May 14, 2009

Conditions

Hypertension, Pulmonary

Keywords

Primary or secondary Pulmonary hypertensionIloprostInhaledLong-term treatment

Outcome Measures

Primary Outcomes (2)

  • Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange

  • Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Secondary Outcomes (7)

  • Overall clinical tolerability of the long-term use of iloprost aerosol

  • Serious Adverse Events and deaths

  • Effect of long-term administration of inhaled iloprost on mortality and transplantation

  • Exercise capacity

  • Acute effect of inhaled iloprost on hemodynamics and gas exchange

  • +2 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Ventavis (Iloprost, BAYQ6256)DRUG
Arm 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients
  • Secondary pulmonary hypertension
  • Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
  • Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study

You may not qualify if:

  • Clinical Instability at baseline
  • Pulmonary venous obstruction
  • Global respiratory insufficiency
  • Obstructive ventilation disorders, Interstitial pulmonary disease
  • Cerebrovascular events
  • Myocardial infarction or major cardiac surgery within 3 months prior to baseline
  • Bleeding disorders or bleeding risk
  • Severe hepatic insufficiency or renal insufficiency
  • Malignant diseases
  • HIV positive
  • Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers
  • Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension
  • Prior pulmonary embolism
  • Collagenosis
  • Pulmonary arterial or valvular stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11.

    PMID: 20153158DERIVED

MeSH Terms

Conditions

Hypertension, PulmonaryRespiratory Aspiration

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

July 1, 1998

Study Completion

May 1, 2001

Last Updated

May 15, 2009

Record last verified: 2009-05