NCT02825160

Brief Summary

This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 15, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

6.7 years

First QC Date

June 15, 2016

Last Update Submit

August 15, 2024

Conditions

Hypertension, Pulmonary

Keywords

IloprostVentavisProstacycline analoguePulmonary arterial hypertensionJapanPost-marketing surveillance

Outcome Measures

Primary Outcomes (2)

  • Number of participants with treatment emergent adverse events (TEAE) of special interest.

    TEAE of special interest: * Hypotension * Syncope * Local irritation * Bleeding events * Thrombocytopenia * Tachycardia

    Up to 5 years

  • Number of participants with adverse drug reaction

    Up to 5 years

Secondary Outcomes (6)

  • Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months

    Baseline and 3 months,Baseline and 12 months,

  • Change from baseline in 6-Minute Walking Distance after 3 and 12 months

    Baseline and 3 months,Baseline and 12 months

  • Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months

    Baseline and 3 months,Baseline and 12 months

  • Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.

    Baseline and 3 months,Baseline and 12 months

  • Change from baseline in WHO functional class after 3 and 12 months

    Baseline and 3 months,Baseline and 12 months,

  • +1 more secondary outcomes

Study Arms (1)

Ventavis

Ventavis treatment group

Drug: Ventavis (Iloprost, BAYQ6256)

Interventions

Ventavis (Iloprost, BAYQ6256)DRUG

The treatment of Ventavis should comply with the local product information

Ventavis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population includes PAH patients treated with Ventavis. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Ventavis for PAH need to be registered in principle, until the target number of patients reached.

You may qualify if:

  • Patients diagnosed with PAH
  • Patients for whom the decision to initiate treatment with Ventavis was made as per investigator's routine treatment practice.

You may not qualify if:

  • \- N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

Related Links

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 7, 2016

Study Start

August 1, 2016

Primary Completion

March 31, 2023

Study Completion

September 27, 2023

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

JP(1)