Long-Term Open-Label Extension Study of Oral Levosimendan

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Tenax Therapeutics, Inc.
Study ID
NCT07436689
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Pulmonary Hypertension Associated With HFpEF

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • TNX-103 — DRUG
    Open-label oral levosimendan 1-3mg

Study Details

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.

Key Dates

Start date
Mar 13, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TNX-103
    Open-label oral levosimendan 1-3mg

Primary Outcome Measure

The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs [ Time Frame: From enrollment through study completion (up to 3 years) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Tenax Investigational SiteChicagoIllinois60611-
Tenax Investigational SiteMinneapolisMinnesota55455-
Tenax Investigational SiteRochesterMinnesota55905-
Tenax Investigational SiteSt LouisMissouri63136-
Tenax Investigational SiteCharlestonSouth Carolina29425-

Find similar trials in Chicago, IL

By research site
Tenax Investigational Site· Chicago, ILTenax Investigational Site· Minneapolis, MNTenax Investigational Site· Rochester, MNTenax Investigational Site· St Louis, MOTenax Investigational Site· Charleston, SC

Related Studies