Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)
NCT02032836 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2018-09-26
Summary
Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb
Conditions
Interventions
- DRUG
-
lloprost(Ventavis,BAYQ6252, 20 µg/mL)
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
- DRUG
-
lloprost(Ventavis,BAYQ6252, 10 µg/mL)
10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-10
- Primary Completion
- 2015-01-07
- Completion
- 2017-09-29
Countries
- Austria
- Germany
Study Locations
More Related Trials
-
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
NCT01469169 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
NCT01781052 ·Status: COMPLETED
-
Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
NCT01389271 ·Status: COMPLETED
-
Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension
NCT00414687 ·Status: COMPLETED ·Phase: PHASE2
-
Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)
NCT01062282 ·Status: COMPLETED
-
Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
NCT02825160 ·Status: COMPLETED
-
Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
NCT00250640 ·Status: COMPLETED
-
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)
NCT00882947 ·Status: COMPLETED
-
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
NCT00120380 ·Status: TERMINATED ·Phase: PHASE4
-
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction
NCT00458042 ·Status: TERMINATED ·Phase: PHASE4
-
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
NCT00640315 ·Status: COMPLETED ·Phase: PHASE1
-
Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
NCT01971450 ·Status: COMPLETED
-
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
NCT01437878 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
NCT03556020 ·Status: TERMINATED ·Phase: PHASE2
-
Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial Hypertension
NCT01054105 ·Status: COMPLETED
-
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
NCT04691154 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
NCT02725372 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
NCT00810693 ·Status: COMPLETED ·Phase: PHASE3
-
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
NCT00723554 ·Status: TERMINATED ·Phase: PHASE3
-
Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
NCT03365479 ·Status: COMPLETED ·Phase: NA
-
Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)
NCT00694850 ·Status: COMPLETED ·Phase: PHASE2
-
Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System
NCT01468545 ·Status: COMPLETED
-
Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
NCT04231084 ·Status: COMPLETED ·Phase: PHASE4
-
Ventavis® Registry Protocol
NCT00902603 ·Status: TERMINATED
-
Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
NCT00235521 ·Status: COMPLETED ·Phase: NA