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NCT05983250 · ClinicalTrials.gov registry record · Phase 3
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
A Phase 3 study of Pulmonary Hypertension, sponsored by Tenax Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT05983250: Recruiting Phase 3 study of Pulmonary Hypertension, sponsored by Tenax Therapeutics.
NCT05983250 is a Phase 3 study of Pulmonary Hypertension that is actively recruiting participants, run by Tenax Therapeutics. The registered enrollment target is 230 participants, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05983250, a Phase 3 study of Pulmonary Hypertension, is actively recruiting participants, sponsored by Tenax Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TNX-103
Study Locations (20)
California
- Tenax Investigational Site - La Jolla
- Tenax Investigational Site - Los Angeles
- Tenax Investigational Site - Los Angeles
- Tenax Investigational Site - Sacramento
- Tenax Investigational Site - San Francisco
- Tenax Investigational Site - Torrance
Illinois
- Tenax Investigational Site - Chicago
- Tenax Investigational Site - Chicago
- Tenax Investigational Site - Galesburg
Florida
- Tenax Investigational Site - Jacksonville
- Tenax Investigational Site - Winter Haven
Indiana
- Tenax Investigational Site - Indianapolis
- Tenax Investigational Site - Indianapolis
Minnesota
- Tenax Investigational Site - Minneapolis
- Tenax Investigational Site - Rochester
Arizona
- Tenax Investigational Site - Tucson
Georgia
- Tenax Investigational Site - Atlanta
Kentucky
- Tenax Investigational Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
What NCT05983250 shows while recruiting
NCT05983250 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05983250 names 20 study sites across 10 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT05983250 about?
NCT05983250 is a clinical study titled "LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF". 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).
What is the current status of trial NCT05983250?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2024-01-10. Estimated completion is 2028-10.
What conditions does trial NCT05983250 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT05983250?
The interventions under investigation include: Placebo (DRUG), TNX-103 (DRUG).
Who is sponsoring clinical trial NCT05983250?
This trial is sponsored by Tenax Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05983250 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05983250's enrollment target sits among peer trials
230 21st of 72 higher than 51 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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