NCT02882126

An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003

• Status: Withdrawn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 a multicenter, open-label trial to evaluate the safety of continued therapy with subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial centers in China who completed all required assessments in the CVT-CV-003 study. Study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Subcutaneous Treprostinil	Remodulin (1.0, 2.5, 5 and 10 mg/ml formulations as available) will be administered by continuous subcutaneous infusion via a subcutaneous cannula using a microbore infusion tubing set and a micro infusion pump.

Timeline

• Start date: 2017-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2016-08-29
• Last updated: 2017-05-09

Locations

10 sites across 1 country: China

Regulatory

• FDA-regulated drug study