Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT00185315
  4. Details
NCT00185315 Clinical Trial

Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

Official title:
Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185315
Other study ID # 90570
Secondary ID 303045Follow-up
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated April 19, 2010
Start date February 2000
Est. completion date August 2005

Study information
Verified date April 2010
Source Bayer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Ministry of Health and ConsumptionPortugal: National Pharmacy and Medicines InstitutePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial Summary

The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Description:

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 71 Years
Eligibility Inclusion Criteria:

- Completion of the 12-week treatment period of the predecessor Schering study 97218/300180

- Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient

- Negative pregnancy test for females

Exclusion Criteria:

- Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ventavis (Iloprost, BAYQ6256)
Inhaled iloprost

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  Poland,  Portugal,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Throughout the whole study
Secondary Tolerability of treatment Over a minimum of 24 months
See also
  Status Clinical Trial Phase
Completed NCT04095286 - Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants Phase 1
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT02191137 - Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) Phase 4
Completed NCT01959828 - Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery Phase 3
Withdrawn NCT01202045 - Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients N/A
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT01121458 - Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed Phase 4
Terminated NCT00825266 - Insulin Resistance in Pulmonary Arterial Hypertension Phase 4
Terminated NCT00384865 - A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension Phase 2
Active, not recruiting NCT03926572 - Acute Decompensation of Pulmonary Hypertension N/A
Completed NCT02826252 - Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20) N/A
Completed NCT02545465 - A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice N/A
Recruiting NCT04498299 - Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
Recruiting NCT02558582 - Effect of Exercise Training in Patients With Pulmonary Hypertension N/A
Active, not recruiting NCT02562235 - Riociguat in Children With Pulmonary Arterial Hypertension (PAH) Phase 3
Completed NCT02755298 - Chronic Clinical Effect of Acetazolamide Phase 2/Phase 3
Completed NCT02576002 - Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) N/A
Terminated NCT03043976 - Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension N/A
Completed NCT01317134 - Endothelial Function in Patients With Pulmonary Arterial Hypertension N/A

External Links