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Clinical Trials List

Protocol NumberTNX-103-07

NCT Number(ClinicalTrials.gov Identfier)NCT07288398

Not yet recruiting

2026-01-02 - 2029-09-30

Phase III

Not yet recruiting1

Recruiting5

ICD-10I27.2

Other secondary pulmonary hypertension

ICD-10I27.89

Other specified pulmonary heart diseases

ICD-9416.8

Other chronic pulmonary heart diseases

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor

PHARMACEUTICAL RESEARCH ASSOCIATES TAIWAN INC.
Trial scale

Multi-Regional Multi-Center
Update

2026/09/10

Investigators and Locations

Principal Investigator Tsung-Hsien Lin 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Chun-Yuan Chu 無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 李威杰無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Yi Hsu 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳懿哲無

MacKay Memorial Hospital

Co-Principal Investigator

吳書豪無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭風裕無

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pao-Hsien Chu

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Hypertension Associated With HFpEF

Objectives

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.

Test Drug

Levosimendan

Active Ingredient

Levosimendan

Dosage Form

Capsules

Dosage

1mg

Endpoints

6-Minute Walk Distance (6MWD) Change in 6-minute walk distance 26 weeks

Inclution Criteria

Men or women, ≥18 to 85 years of age
NYHA Class II or III or ambulatory NYHA Class IV symptoms
A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
A qualifying baseline RHC
A qualifying echocardiogram
A qualifying 6-MWD
A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
Requirements related to child bearing potential, contraception, and egg/sperm donation)

Exclusion Criteria

A diagnosis of PH WHO Groups 1, 3, 4, or 5
Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease
A diagnosis of pre-existing lung disease
History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
Major surgery within 60 days
Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
History of clinically significant other diseases that may limit or complicate participation in the study

The Estimated Number of Participants

Taiwan

16 participants
Global

540 participants