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Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)

NCT02847260 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-10-17

Study results available
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Summary

The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration regimen of subcutaneous Remodulin® therapy in patients with PAH.

Conditions

Interventions

DRUG

Remodulin

Treatment will be initiated whilst hospitalized at approximately 2.0 ng/kg/min with dose increments of 1- 2 ng/kg/min approximately every 12 hours according to clinical response and tolerability. Following subject discharge, the dose rate is increased by 1-2 ng/kg/min with dose increments separated by at least 24 hours. When a dose rate of 20 ng/kg/min is achieved dose increments can be increased at a rate of up to 4 ng/kg/min with dose increments separated by at least 24 hours depending on tolerability. The aim is to achieve a dose rate of at least 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively and a dose rate by the end of week 16 that achieves pre-defined treatment goals subject to clinical response and tolerability.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Grünig · Thoraxklinik am Universitätsklinikum, Heidelberg, Germany

  • Klose · Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

  • Rosenkranz · Universitätsklinikum Köln, Köln, Germany

  • Höffken · Universitaetsklinikum Dresden, Dresden, Germany

  • Lange · Universitätsklinikum Regensburg, Regensburg, Germany

  • Wirtz · Universitätsklinikum Leipzig, Leipzig, Germany

  • Neurohr · Klinikum Großhadern der LMU, Munich, Germany

  • Wilkens · Universitätsklinikum Klinik, Homburg, Germany

  • Held · Missionsärztliche Klinik, Würzburg, Germany

  • Krüger · Herzzentrum Duisburg, Duisburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

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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 NCT02847260 on ClinicalTrials.gov