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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05983250
The ClinicalTrials.gov registry entry for NCT05983250 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (62% lower). The listed sponsor is Tenax Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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