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Levosimendan in Pulmonary Hypertension Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction - Trial NCT05983250

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.

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NCT05983250
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05983250
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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)

Study Focus

Pulmonary Hypertension

TNX-103

Interventional

drug

Sponsor & Location

Tenax Therapeutics, Inc.

Timeline & Enrollment

Phase 3

Nov 01, 2023

Jul 01, 2027

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 hypertension
Other secondary pulmonary hypertension
Pulmonary heart disease and diseases of pulmonary circulation
Pulmonary heart disease, unspecified
Pulmonary valve disorders

Data Source

ClinicalTrials.gov

NCT05983250

Non-Device Trial