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NCT05128929 · ClinicalTrials.gov registry record · Phase 2
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
A Phase 2 study of Pulmonary Hypertension, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT05128929: Completed Phase 2 study of Pulmonary Hypertension, sponsored by Stanford University.
NCT05128929 is a Phase 2 study of Pulmonary Hypertension that has completed, run by Stanford University. The registered enrollment target is 17 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05128929, a Phase 2 study of Pulmonary Hypertension, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Calculated pulmonary vascular resistance (PVR) measured by right heart catheterization (RHC). A normal PVR ranges between 0.25 and 1.6 wood units (WU). Pre-capillary pulmonary hypertension is characterized by a PVR greater than 3 WU. Greater PVR is indicative of increased disease severity. Either Fick or Thermodilution method can be utilized to measure cardiac output (CO) and calculate PVR. Fick method utilizes estimated oxygen consumption to measure CO and calculate PVR, while the thermodilut
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hymecromone (H01)
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
What the finished NCT05128929 record still lists
NCT05128929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05128929 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05128929 about?
NCT05128929 is a clinical study titled "Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).". 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 o...
What is the current status of trial NCT05128929?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2022-04-01. Estimated completion is 2023-09-29.
What conditions does trial NCT05128929 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT05128929?
The interventions under investigation include: Placebo (DRUG), Hymecromone (H01) (DRUG).
Who is sponsoring clinical trial NCT05128929?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05128929 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05128929's enrollment target sits among peer trials
17 63rd of 72 higher than 10 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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