At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 17 enrolled

Drug / intervention

Hymecromone (H01) +1 moredrug

Likely dose

Hymecromone (H01) 800 mgfrom 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/NCT05128929

NCT05128929Phase 2Completed

Compare CT.gov

Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).

Stanford University·interventional·Posted Nov 22, 2021·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating Hymecromone (H01) and Placebo for Pulmonary Hypertension. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks. Study Hypothesis: Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPulmonary Hypertension

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20222023202420252026

First PostedNov 2021

Enrollment StartApr 2022

Primary CompletionSep 2023

Study CompletionSep 2023

TodayJul 2026

First PostedNov 22, 2021

Enrollment StartApr 1, 2022

Primary CompletionSep 21, 2023

Study CompletionSep 29, 2023

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 4.6 years ago

Interventions

Hymecromone (H01)drug

800 mg oral H01 two times a day (total dose: 1600 mg/day).

Placebodrug

Oral tablet placebo (inactive ingredients) two times a day.