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Enrolling By Invitation NCT07436689

Long-Term Open-Label Extension Study of Oral Levosimendan

Conditions: Pulmonary Hypertension Associated With HFpEF

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 800
Sponsor: Tenax Therapeutics, Inc.

Location: Tenax Investigational Site Chicago Illinois

Summary

The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07436689). StuddyBuddy aggregates publicly available trial information.