NCT02893995

Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension

A 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, parallel, randomized (1:1 Slow Dose Titration Group; Rapid Dose Titration Group), two-group study to evaluate the safety, tolerability, pharmacokinetics and efficacy of slow and rapid dose titration regimens of subcutaneous Remodulin infusion in subjects with pulmonary arterial hypertension (PAH). The study will include about 50 subjects at up to 10 clinical trial centers in China. The treatment phase of the study will last approximately 16 weeks. Subjects who complete all required assessments will also be eligible to enter a long-term open-label, extension study (CVT-CV-004).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Slow Dose Titration Group of Subcutaneous Treprostinil	subcutaneous treprostinil
DRUG	Rapid Dose Titration Group of Subcutaneous Treprostinil	subcutaneous treprostinil

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-09-09
• Last updated: 2017-05-09

Locations

10 sites across 1 country: China

Regulatory

• FDA-regulated drug study