LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Tenax Therapeutics, Inc.
Study ID
NCT05983250
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

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

Interventions

  • TNX-103 — DRUG
    oral levosimendan 1 mg
  • Placebo — DRUG
    Placebo

Study Details

This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

Key Dates

Start date
Jan 10, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo
  • Active Comparator: TNX-103
    oral levosimendan

Primary Outcome Measure

Change in Six-minute walk distance [ Time Frame: 12 weeks ]

Central Contacts

Locations (41)

FacilityCityStateZIPSite coordinators
Tenax Investigational SiteTucsonArizona85721-
Tenax Investigational SiteLa JollaCalifornia92037-
Tenax Investigational SiteLos AngelesCalifornia90033-
Tenax Investigational SiteLos AngelesCalifornia90048-
Tenax Investigational SiteSacramentoCalifornia95817-
Tenax Investigational SiteSan FranciscoCalifornia94143-
Tenax Investigational SiteTorranceCalifornia90502-
Tenax Investigational SiteJacksonvilleFlorida32224-
Tenax Investigational SiteWinter HavenFlorida33881-
Tenax Investigational SiteAtlantaGeorgia30322-
Tenax Investigational SiteChicagoIllinois60208-
Tenax Investigational SiteChicagoIllinois60637-
Tenax Investigational SiteGalesburgIllinois61401-
Tenax Investigational SiteIndianapolisIndiana46202-
Tenax Investigational SiteIndianapolisIndiana46260-
Tenax Investigational SiteLouisvilleKentucky40202-
Tenax Investigational SiteBostonMassachusetts02114-
Tenax Investigational SiteMinneapolisMinnesota55455-
Tenax Investigational SiteRochesterMinnesota55905-
Tenax Investigational SiteSt LouisMissouri63136-
Tenax Investigational SiteOmahaNebraska68198-
Tenax Investigational SiteNew YorkNew York10021-
Tenax Investigational SiteNew YorkNew York10029-
Tenax Investigational SiteRochesterNew York14621-
Tenax Investigational SiteRoslynNew York11576-
Tenax Investigational SiteCharlotteNorth Carolina28203-
Tenax Investigational SiteDurhamNorth Carolina27710-
Tenax Investigational SiteGreensboroNorth Carolina27401-
Tenax Investigational SiteCincinnatiOhio45267-
Tenax Investigational SiteColumbusOhio43214-
Tenax Investigational SitePittsburghPennsylvania15212-
Tenax Investigational SiteProvidenceRhode Island02903-
Tenax Investigational SiteCharlestonSouth Carolina29425-
Tenax Investigational SiteColumbiaSouth Carolina29044-
Tenax Investigational SiteDallasTexas75204-
Tenax Investigational SiteDallasTexas75390-
Tenax Investigational SiteLubbockTexas79430-
Tenax Investigational SitePlanoTexas75093-
Tenax Investigational SiteMurrayUtah84107-
Tenax Investigational SiteRichmondVirginia23298-
Tenax Investigational SiteMadisonWisconsin53792-

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