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Hymecromone (H01) for Pulmonary Hypertension (SATURN Trial)

Phase 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment (week 24)
Awards & highlights

SATURN Trial Summary

This trial will study the safety and efficacy of Hymecromone in treating pulmonary hypertension.

Eligible Conditions
  • Pulmonary Hypertension

SATURN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment (week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pulmonary Vascular Resistance (PVR)
Secondary outcome measures
6 Minute Walk Distance Test (6 MWDT)
Change in Mean Pulmonary Arterial Pressure (mPAP)
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
+3 more
Other outcome measures
Exhaled breath condensate (EBC) hyaluronan concentrations
Forced Expiratory Volume in one second (FEV1)
Forced Vital Capacity (FVC) from Pulmonary Function Test (PFT)
+6 more

SATURN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Treatment Oral Hymecromone (H01)Experimental Treatment1 Intervention
Treatment will be initiated. Participants will be administered 800 mg of oral H01 two times a day (total dose: 1600 mg/day). Participants will continue to be on treatment for 24 weeks and will be monitored with assessments.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive oral tablet placebo (inactive ingredients) two times a day. Participants will continue to be on placebo for 24 weeks and will be monitored with assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hymecromone (H01)
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,034 Total Patients Enrolled

Media Library

Hymecromone (H01) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05128929 — Phase 2
Pulmonary Hypertension Research Study Groups: Experimental Treatment Oral Hymecromone (H01), Placebo
Pulmonary Hypertension Clinical Trial 2023: Hymecromone (H01) Highlights & Side Effects. Trial Name: NCT05128929 — Phase 2
Hymecromone (H01) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128929 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for eligibility in this clinical study?

"Patients with hypertension and pulmonary disease who are between the ages of 18 to 75 can qualify for this medical trial. A total of 16 people is needed in order to complete enrolment."

Answered by AI

What is the aggregate figure of participants involved in this medical investigation?

"Affirmative. The information on clinicaltrials.gov confirms that this medical trial, which was first published on April 1st 2022, is actively enrolling patients. 16 participants are needed from a single site to complete the study."

Answered by AI

Is the enrollment for this clinical study open to senior citizens?

"This medical trial is open to 18-75 year old patients. Additionally, there are 82 trials available for minors and 934 studies catered to the elderly population."

Answered by AI

What medical conditions has Hymecromone (H01) been found to be most effective in managing?

"Cholelithiasis is often managed with the Hymecromone (H01) medication. This pharmaceutical can also be beneficial for patients suffering from gallbladder inflammation, dyspepsia, and mild to moderate hepatic insufficiency."

Answered by AI

To what extent could Hymecromone (H01) jeopardize patient safety?

"Although the data does not provide evidence for Hymecromone's (H01) efficacy, it indicates that its safety is likely high; thus, our team at Power has ascribed a score of 2 to this medication."

Answered by AI

Is there an opportunity for new participants in this experiment?

"According to the data on clinicaltrials.gov, this research endeavour is in search of participants and has been since April 1st 2022. The trial was recently updated at the end of May."

Answered by AI

Has the drug Hymecromone (H01) been evaluated in any prior medical investigations?

"Presently, one clinical trial examining Hymecromone (H01) is in progress and zero trials have reached Phase 3. Primarily located at Stanford University, California; there exists a single medical centre that is conducting research on the drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
Roham T. Zamanian 2022. "Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128929.
~5 spots leftby Apr 2025
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