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NCT05983250Not yet recruiting

Levosimendan in Pulmonary Hypertension Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Tenax Therapeutics, Inc.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Hypertension
Drug/Device/Intervention
TNX-103
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Tenax Therapeutics, Inc.
Timeline & enrollment
Phase
Phase 3
Start date
Nov 01, 2023
End date
Jul 01, 2027
Enrollment
152 participants
Primary outcome

Six-minute walk distance from Baseline to Week 12

Summary

This study will evaluate the efficacy of TNX-103 (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).

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationPulmonary heart disease, unspecifiedPulmonary valve disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05983250
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05983250 through Pure Global AI's free database. This Phase 3 trial is sponsored by Tenax Therapeutics, Inc. and is currently Not yet recruiting. The study focuses on Pulmonary Hypertension. Target enrollment is 152 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.