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NCT07436689

Long-Term Open-Label Extension Study of Oral Levosimendan

Enrolling by Invitation
PHASE3All AgesInterventionalTreatment
Tenax Therapeutics, Inc.
~800 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:TNX-103

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
Measured over From enrollment through study completion (up to 3 years)

Conditions

Pulmonary Hypertension Associated With HFpEF

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Pulmonary Hypertension Associated With HFpEF

Where it's being run

7 sites across 6 states
Minnesota2
Illinois1
Missouri1
Nebraska1
South Carolina1
Wisconsin1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Completed a TNX-103 parent study
Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103
Requirements related to childbearing potential, contraception, and egg/sperm donation

Exclusion

Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being
Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication
Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²
Pregnancy or breastfeeding in females

What this trial measures

  • The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEsFrom enrollment through study completion (up to 3 years)

    The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.