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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan Open-Label | Other | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Safety | Number of Adverse Events per Patient Population | Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Rich, MD | Tenax Therapeutics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Healthcare | Stanford | California | 94305 | United States | ||
| Northwestern Memorial Hospital |
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Patients completing the Phase 2 HELP Study (TNX-LVO-04) were consented to open-label levosimendan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levosimendan Open-Label | Patients received weekly levosimendan IV infusions transitioned to oral levosimendan (1mg capsules) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2021 | Mar 11, 2026 |
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Open-label
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| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UW Health University Hospital | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levosimendan IV Transitioned to Levosimendan Capsules (1mg) | Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for weekly 24 hour infusion. Transitioned To: Levosimendan Capsules (1mg TID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Safety | Number of Adverse Events per Patient Population | All patients consenting to enrollment in the study. | Posted | Count of Participants | Participants | Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit). |
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2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levosimendan Open-Label | Ongoing patients receiving weekly levosimendan IV infusions transitioned to daily oral levosimendan | 2 | 35 | 24 | 35 | 15 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| General disorders | General disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Vascular disorders | Vascular disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 21.0 | Non-systematic Assessment |
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| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Product issues | Product Issues | MedDRA, version 21.0 | Non-systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Non-systematic Assessment |
| |
| General disorders | General disorders | MedDRA, version 21.0 | Non-systematic Assessment |
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This was an uncontrolled observational study of patients transitioning from a controlled study to open-label levosimendan. After an average of 11.5 months on study, ongoing patients were transitioned from a weekly IV infusion regimen to daily oral levosimendan.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Hay | Tenax Therapeutics | 1-919-855-2110 | d.hay@tenaxthera.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2023 | Mar 11, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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