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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of treatment (week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 24)
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 moreOther 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 moreSATURN 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
2,408 Previous Clinical Trials
17,343,232 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment Oral Hymecromone (H01)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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