CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 105 enrolled
Drug / intervention
Treprostinil sodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01416636
NCT01416636Phase 3Completed
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A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)

SciPharm SàRL·interventional·Posted Aug 15, 2011·Updated Jun 7, 2022

In Brief

A Phase 3 clinical trial evaluating Treprostinil sodium for Non-operable Chronic Thromboembolic Pulmonary Hypertension. Completed, enrolled 105 participants across 6 sites in 4 countries.

Detailed Summary

The primary purpose of this study is to determine the effect on six-minute walking test (6MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-operable Chronic Thromboembolic Pulmonary Hypertension
CountriesAustria, Czechia, Germany, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2011
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2016
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 14.9 years ago

Interventions

Treprostinil sodiumdrug