Trial Outcomes & Findings for Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF (NCT NCT03541603)
NCT ID: NCT03541603
Last Updated: 2024-11-20
Results Overview
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2024-11-20
Participant Flow
44 patients satisfied entry criteria for enrollment and received lead-in open-label levosimendan. 37 of the 44 enrolled patients achieved responder criteria following 24hr lead-in open label levosimendan infusion and were randomized to study
Participant milestones
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Baseline characteristics by cohort
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=19 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: patients completing Baseline and Week 6 visit with hemodynamic data
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise
|
-1.9 mmHg
Standard Deviation 10.07
|
-0.5 mmHg
Standard Deviation 7.87
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: patients completing Baseline and Week 6 visit with hemodynamic data
Change in Cardiac Index (CI) at rest and with exercise at Week 6 (CI determined by thermodilution) (CI is a hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA))
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Change in Cardiac Index (CI) at Rest and With Exercise.
rest
|
0.05 L/min/m^2
Standard Deviation 0.699
|
-0.15 L/min/m^2
Standard Deviation 0.262
|
|
Change in Cardiac Index (CI) at Rest and With Exercise.
exercise
|
0.24 L/min/m^2
Standard Deviation 1.106
|
0.04 L/min/m^2
Standard Deviation 0.594
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: patients completing Baseline and Week 6 visit with hemodynamic data
Change in Pulmonary Vascular Resistance (PVR) effect at rest and with exercise at Week 6
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise
rest
|
-0.09 mmHg.min/L
Standard Deviation 1.050
|
0.15 mmHg.min/L
Standard Deviation 2.238
|
|
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise
exercise
|
-0.44 mmHg.min/L
Standard Deviation 1.539
|
-0.16 mmHg.min/L
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: patients completing Baseline and Week 6 visit with hemodynamic data
Change in Pulmonary Capillary Wedge Pressure, Baseline to Week 6
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Change in PCWP When Supine and Legs Elevated
rest
|
-5.1 mmHg
Standard Deviation 5.26
|
-1.7 mmHg
Standard Deviation 6.14
|
|
Change in PCWP When Supine and Legs Elevated
legs elevated
|
-6.0 mmHg
Standard Deviation 7.75
|
-0.3 mmHg
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: Baseline, Week 6Patient assessment of well-being based on 6 questions assessed on a 5-point Likert Scale ( 1 =worst, 5= best) (minimum total score 5pts, maximum total score 25 pts) (no comparison to baseline as no instrument used at baseline)
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Patient Global Assessment
|
3 units on a scale
Interval 3.0 to 4.0
|
3 units on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Week 6Change in 6-minute walk test at Week 6 vs baseline
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Exercise Duration Via 6 Minute Walk Test
|
16.6 meters
Standard Deviation 40.03
|
-12.8 meters
Standard Deviation 35.08
|
SECONDARY outcome
Timeframe: Baseline, Week 6Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity).
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Physician's Assessment of Functional Class
Baseline · Class III
|
16 Participants
|
14 Participants
|
|
Physician's Assessment of Functional Class
Baseline · Class IV
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Functional Class
Week 6 · Class I
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Functional Class
Week 6 · Class II
|
8 Participants
|
5 Participants
|
|
Physician's Assessment of Functional Class
Baseline · Class I
|
0 Participants
|
0 Participants
|
|
Physician's Assessment of Functional Class
Baseline · Class II
|
2 Participants
|
3 Participants
|
|
Physician's Assessment of Functional Class
Week 6 · Class III
|
10 Participants
|
12 Participants
|
|
Physician's Assessment of Functional Class
Week 6 · Class IV
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Number of Participants with Composite Events of death or hospitalization through Week 6
Outcome measures
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=17 Participants
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Number of Participants With Composite Events of Death or Hospitalization
|
3 Participants
|
1 Participants
|
Adverse Events
Levosimendan 2.5mg/mL Injectable Solution
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 participants at risk
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=19 participants at risk
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
Infections and infestations
Device related infection
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
Other adverse events
| Measure |
Levosimendan 2.5mg/mL Injectable Solution
n=18 participants at risk
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Levosimendan: 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
|
Matching Placebo
n=19 participants at risk
0.075 - 0.1µg/kg/min for 24 hrs (weekly)
Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
|
|---|---|---|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
10.5%
2/19 • Number of events 2 • 6 weeks
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
General disorders
Infusion site hemorrhage
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
General disorders
Infusion site erythema
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
General disorders
Edema
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Extrasystoles
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Cellulitis
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Device-related infection
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Infections and infestations
Tooth abscess
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Balance disorder
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/18 • 6 weeks
|
10.5%
2/19 • Number of events 2 • 6 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Injury, poisoning and procedural complications
Underdose
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Investigations
Heart rate increased
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Investigations
Body temperature increased
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Product Issues
Device infusion issue
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Product Issues
Device dislocation
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Product Issues
Device occlusion
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Vascular disorders
Thrombophlebitis
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Eye disorders
Vison blurred
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
Additional Information
Stuart Rich, MD; Chief Medical Officer
Tenax Therapeutics, Inc.
Phone: 919 855 2100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place