LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
Tenax Therapeutics, Inc.
Study ID
NCT07288398
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pulmonary Hypertension Associated With HFpEF

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TNX-103 — DRUG
    Oral levosimendan
  • Placebo — DRUG
    Matching placebo (oral)

Study Details

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

Key Dates

Start date
Mar 3, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Matching placebo (oral)
  • Active Comparator: TNX-103
    Oral levosimendan

Primary Outcome Measure

6-Minute Walk Distance (6MWD) [ Time Frame: 26 weeks ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Tenax Investigational SiteAlexander CityAlabama35010-
Tenax Investigational SiteTamaracFlorida33321-
Tenax Investigational SiteMount ProspectIllinois60056-
Tenax Investigational SitePeoriaIllinois61636-
Tenax Investigational SiteNew OrleansLouisiana70115-6969-
Tenax Investigational SiteWest MonroeLouisiana71291-
Tenax Investigational SiteYpsilantiMichigan48197-
Tenax Investigational SiteRenoNevada89502-
Tenax Investigational SiteNew YorkNew York10032-
Tenax Investigational SiteWinston-SalemNorth Carolina27101-
Tenax Investigational SiteAllentownPennsylvania18105-
Tenax Investigational SiteWynnewoodPennsylvania19096-3450-
Tenax Investigational SiteNashvilleTennessee37205-
Tenax Investigational SiteAustinTexas78705-
Tenax Investigational SiteDallasTexas75390-
Tenax Investigational SiteHoustonTexas77002-
Tenax Investigational SiteNorfolkVirginia23507-1904-
Tenax Investigational SiteMarshfieldWisconsin54449-

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Tenax Investigational Site· Alexander City, ALTenax Investigational Site· Tamarac, FLTenax Investigational Site· Mount Prospect, ILTenax Investigational Site· Peoria, ILTenax Investigational Site· New Orleans, LATenax Investigational Site· West Monroe, LA

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