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NCT03624010 · ClinicalTrials.gov registry record · Phase 2
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
A Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure, sponsored by Tenax Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 9
- Study locations
NCT03624010 is a Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure that has completed, run by Tenax Therapeutics. The registered enrollment target is 20 participants, below the 638-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (97% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT03624010, a Phase 2 study of Heart Failure With Normal Ejection Fraction and Hypertension Pulmonary Secondary Heart Failure, has completed, sponsored by Tenax Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 9
- Study locations
Study Summary
PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Conditions Studied
Interventions
- DRUG Levosimendan 2.5 mg/ml Injectable Solution
Study Locations (9)
Minnesota
- University of Minnesota Medical Center - Minneapolis
- Mayo Clinic - Rochester
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- UPMC Presbyterian Hospital - Pittsburgh
California
- Stanford Healthcare - Stanford
Illinois
- Northwestern Memorial Hospital - Chicago
Nebraska
- University of Nebraska Medical Center - Omaha
South Carolina
- Medical University of South Carolina - Charleston
Wisconsin
- UW Health University Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03624010
The ClinicalTrials.gov registry entry for NCT03624010 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 638-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (97% lower). The listed sponsor is Tenax Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Heart Failure With Normal Ejection Fraction appearing as the primary indexed condition, and to 1 intervention - of which Levosimendan 2.5 mg/ml Injectable Solution is the first listed.
NCT03624010 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Minnesota, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT03624010 about?
NCT03624010 is a clinical study titled "Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients". PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
What is the current status of trial NCT03624010?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-11-14. Estimated completion is 2024-02-01.
What conditions does trial NCT03624010 study?
This clinical trial studies the following conditions: Heart Failure With Normal Ejection Fraction, Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction.
What interventions are being tested in trial NCT03624010?
The interventions under investigation include: Levosimendan 2.5 mg/ml Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT03624010?
This trial is sponsored by Tenax Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03624010 being conducted?
This trial has 9 study locations across California, Illinois, Minnesota, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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