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Clinical Trial Summary

This is a clinical trial to assess the efficacy and safety of LAM-001 as an add-on therapy for the treatment pulmonary hypertension.


Clinical Trial Description

This is a Phase 2a, single-arm, open-label, exploratory study assessing the efficacy and safety of LAM-001 as an add-on therapy for the treatment of WHO functional class III subjects with WSPH Group-1 or Group-3 pulmonary hypertension. Approximately fifteen participants will receive standard of care plus LAM-001 or Placebo once daily for the first 24 weeks of the study (Core Study). Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue receiving LAM-001 for the remainder of the study (Extension Period) up of 12 months. All participants will complete evaluations during a Follow-Up Period of 4 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05798923
Study type Interventional
Source OrphAI Therapeutics
Contact OrphAI Therapeutics
Phone 2034332737
Email aclinical@orphai-therapeutics.com
Status Recruiting
Phase Phase 2
Start date April 3, 2023
Completion date December 31, 2025

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