Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT01355380
  4. Details
NCT01355380 Clinical Trial

Efficacy of Ventavis Used in Real-life Setting.

Pulmonary Arterial Hypertension Clinical Trial

— SPHERA  

Official title:
The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01355380
Other study ID # 15308
Secondary ID VE1010PL
Status Completed
Phase N/A
First received May 17, 2011
Last updated October 16, 2017
Start date August 5, 2010
Est. completion date September 22, 2016

Study information
Verified date October 2017
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date September 22, 2016
Est. primary completion date April 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pulmonary arterial hypertension in WHO functional class III or IV

- Age 18+

- Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

- Retrospective documentation is not allowed

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled iloprost (Ventavis, BAYQ6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of the exercise capacity as measured by 6-minutes walking distance 3, 6, 9 and 12 months vs. baseline
Secondary Changes of depression score over time 3, 6, 9 and 12 months vs. baseline
Secondary Changes of functional capacity as measured by WHO classification system 3, 6, 9 and 12 months vs. baseline
Secondary Changes of pulmonary haemodynamics 3, 6, 9 and 12 months vs. baseline
Secondary Changes of serum level of natriuretic peptide B 3, 6, 9 and 12 months vs. baseline
Secondary Changes of Quality of Life score 3, 6, 9 and 12 months vs. baseline
Secondary Changes in cardiac echo parameters 3, 6, 9 and 12 months vs. baseline
Secondary Number of patients with treatment-emergent adverse events Up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
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
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1

External Links