NCT02092818

Brief Summary

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
26 countries

26 active sites

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

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3.8 years

First QC Date

March 19, 2014

Last Update Submit

June 18, 2019

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (3)

  • Number of adverse events

    Up to 4 years

  • Number of serious adverse events

    Up to 4 years

  • All-cause mortality

    Up to 4 years

Secondary Outcomes (16)

  • Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH)

    Up to 4 years

  • Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH)

    Up to 4 years

  • Incidence of AE of special interest overall

    Up to 4 years

  • Incidence of AE of special interest in different PH indications (PAH, CTEPH)

    Up to 4 years

  • 6 minute walking distance

    Up to 4 years

  • +11 more secondary outcomes

Study Arms (1)

Group 1

Patients who have been prescribed Adempas for a medically appropriate use

Drug: Riociguat (Adempas, BAY63-2521)

Interventions

Riociguat (Adempas, BAY63-2521)DRUG

The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)

Group 1

Eligibility Criteria

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

Patients who have been prescribed Adempas® for a medically appropriate use

You may qualify if:

  • Female and male patients who start or are on treatment with Adempas
  • Written informed consent

You may not qualify if:

  • Patients currently participating in an interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Multiple Locations, Argentina

Location

Unknown Facility

Multiple Locations, Australia

Location

Unknown Facility

Multiple Locations, Austria

Location

Unknown Facility

Multiple Locations, Belgium

Location

Unknown Facility

Multiple Locations, Canada

Location

Unknown Facility

Multiple Locations, Colombia

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Denmark

Location

Unknown Facility

Multiple Locations, Estonia

Location

Unknown Facility

Multiple Locations, Finland

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Greece

Location

Unknown Facility

Multiple Locations, Ireland

Location

Unknown Facility

Multiple Locations, Italy

Location

Unknown Facility

Multiple Locations, Luxembourg

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Norway

Location

Unknown Facility

Multiple Locations, Portugal

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Saudi Arabia

Location

Unknown Facility

Multiple Locations, Slovakia

Location

Unknown Facility

Multiple Locations, Spain

Location

Unknown Facility

Multiple Locations, Sweden

Location

Unknown Facility

Multiple Locations, Switzerland

Location

Unknown Facility

Multiple Locations, Taiwan

Location

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

Unknown Facility

Multiple Locations, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

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

March 19, 2014

First Posted

March 20, 2014

Study Start

May 31, 2014

Primary Completion

March 31, 2018

Study Completion

June 29, 2018

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

AR(1)IE(1)SA(1)ES(1)FR(1)GR(1)NO(1)AU(1)FI(1)DE(1)IT(1)CO(1)TW(1)TU(1)LU(1)DK(1)NL(1)CZ(1)GB(1)CA(1)BE(1)CH(1)RU(1)PT(1)SL(1)SE(1)