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Long-Term Open-Label Extension Study of Oral Levosimendan

NCT07436689 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension Associated With HFpEF

Interventions

DRUG

TNX-103

Open-label oral levosimendan 1-3mg

Sponsors & Collaborators

  • Tenax Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436689 on ClinicalTrials.gov