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Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH

NCT02484807 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2020-02-05

Study results available
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Summary

The development of disease-targeted medication for the treatment of pulmonary arterial hypertension (PAH) has significantly improved within the last years, leading to the development of 10 approved agents. Combination treatment with Endothelin-Receptor-Antagonists (ERA) and Phosphodiesterase-Type-5-Inibitors (PDE-5-Inhibitor) has become increasingly important for the treatment of PAH. In a recent press release, the results of the AMBITION study reported that an upfront combination treatment immediately after diagnosis leads to a delayed disease progression \[4\]. Thus, the question if there is a clinically relevant pharmaco-dynamic drug-drug interaction is of rising interest.

Conditions

Interventions

OTHER

no intervention, only observation of different groups

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Ekkehard Grünig, MD · Thoraxclinic at the University Hospital Heidelberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484807 on ClinicalTrials.gov