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A Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of 3 Doses of CS1 in Subjects With Pulmonary Arterial Hypertension

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Trial Profile

A Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of 3 Doses of CS1 in Subjects With Pulmonary Arterial Hypertension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2024

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At a glance

  • Drugs Valproic acid (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions
  • Sponsors Cereno Scientific

Most Recent Events

  • 04 Oct 2024 Status changed from recruiting to completed.
  • 28 Sep 2024 According to Cereno Scientific media release, On June 28, 2024, company announced the decision to close patient recruitment to the Phase IIa trial CS1-003 by July 1st, 2024, after the Study Clinical Steering Committee concluded that there was sufficient data for evaluating the next steps in development.
  • 28 Sep 2024 According to Cereno Scientific media release, the study, was performed at 10 clinical sites in the US, randomized 25 patients to CS1 treatment, out of which 21 patients completed the treatment without protocol deviations.

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