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Levosimendan for Pulmonary Hypertension and Heart Failure

Enrolling by invitation at 4 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Tenax Therapeutics, Inc.
Disqualifiers: Severe hepatic impairment, eGFR < 30, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive continued access to oral levosimendan (TNX-103) to assess safety in long-term use

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TNX-103

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TNX-103Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tenax Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
1,200+

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