A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy
Phase of Trial: Phase III
Latest Information Update: 10 Nov 2017
At a glance
- Drugs Treprostinil (Primary)
- Indications Pulmonary arterial hypertension
- Focus Therapeutic Use
- Acronyms FREEDOM-Ev
- Sponsors United Therapeutics Corporation
- 07 Sep 2017 According to an United Therapeutics Corporation media release, in accordance with the study protocol and DMC charter, previous interim safety analyses were performed at scheduled intervals throughout the study and was performed after approximately 75% of the target 205 adjudicated clinical worsening (morbidity or mortality) events occurred within the study. The company will remain blinded to results of the study until after the study is completed.
- 07 Sep 2017 According to an United Therapeutics Corporation media release, The DMC's recommendation to continue as planned reflects its review of all available safety and efficacy data, and was made independently. Neither United Therapeutics nor the U.S. Food and Drug Administration (FDA) has reviewed the interim clinical trial results and neither participated in the DMC's closed session deliberation.
- 07 Sep 2017 According to an United Therapeutics Corporation media release, the independent data monitoring committee for the trial had completed a pre-specified interim safety and efficacy analysis. The DMC did not identify any new safety concerns associated with Orenitram therapy, and recommended that the trial be continued as planned without modification.