Trial Outcomes & Findings for Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients (NCT NCT03611010)
NCT ID: NCT03611010
Last Updated: 2022-07-15
Results Overview
LDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline LDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 LDL-C not more than 125% of their baseline.
COMPLETED
PHASE2
40 participants
Baseline, 15 Days
2022-07-15
Participant Flow
Enrollment occurred between 07Aug2018 and 24Feb2020. Three types of patients, categorized by statin use prior to study participation were eligible: patients taking oral atorvastatin, patients taking statins other than atorvastatin, patient not taking any statins prior to study. In Amendment 03. the fourth 80mg dose was eliminated and the 15 days IV route administration was changed to subcutaneous administration.
Participant milestones
| Measure |
Cohort 1
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 2
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 3
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days
|
|---|---|---|---|---|
|
Period 1: Lead-In
STARTED
|
14
|
14
|
2
|
10
|
|
Period 1: Lead-In
COMPLETED
|
14
|
14
|
2
|
10
|
|
Period 1: Lead-In
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2: 15 Day Treatment
STARTED
|
14
|
14
|
2
|
10
|
|
Period 2: 15 Day Treatment
COMPLETED
|
13
|
14
|
2
|
10
|
|
Period 2: 15 Day Treatment
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 2
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 3
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days
|
|---|---|---|---|---|
|
Period 2: 15 Day Treatment
Inaccessible veins
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Baseline characteristics by cohort
| Measure |
Cohort 1
n=14 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=14 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
n=10 Participants
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 8.21 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 18.38 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prior Atorvastatin Use or Using Oral Atorvastatin
Prior Atorvastatin Use or Using Oral Atorvastatin
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Prior Atorvastatin Use or Using Oral Atorvastatin
Prior Statin Other than Atorvastatin Use
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Prior Atorvastatin Use or Using Oral Atorvastatin
No Prior Statin Use
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 15 DaysPopulation: Efficacy Population: A completed group of subjects that 1) finished the two-week treatment period, 2) provided a Day 15 LDL-C level, and 3) took the final targeted dose for that cohort comprised the four efficacy populations.
LDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline LDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 LDL-C not more than 125% of their baseline.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
n=9 Participants
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C
|
9 Participants
|
9 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, 15 DaysPopulation: Efficacy Population: A completed group of subjects that 1) finished the two-week treatment period, 2) provided a Day 15 LDL-C level, and 3) took the final targeted dose for that cohort comprised the four efficacy populations.
HDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline HDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 HDL-C not less than 75% of their baseline.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
n=9 Participants
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C
|
11 Participants
|
13 Participants
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 15 daysPopulation: Efficacy Population: A completed group of subjects that 1) finished the two-week treatment period, 2) provided a Day 15 LDL-C level, and 3) took the final targeted dose for that cohort comprised the four efficacy populations.
Mean change in LDL-C (mg/dL) from baseline at Day 15
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
n=9 Participants
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
Change in Baseline LDL-C Concentration
|
12.36 mg/dL
Standard Deviation 14.740
|
2.62 mg/dL
Standard Deviation 34.844
|
27.50 mg/dL
Standard Deviation 14.849
|
11.22 mg/dL
Standard Deviation 13.283
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
Cmax IV
Atorvastatin
|
284.33 mg/mL
Standard Deviation 189.540
|
830.34 mg/mL
Standard Deviation 1141.919
|
507.50 mg/mL
Standard Deviation 443.456
|
—
|
|
Cmax IV
2-Hydroxy Atorvastatin
|
0.40 mg/mL
Standard Deviation 0.87
|
1.23 mg/mL
Standard Deviation 0.450
|
3.23 mg/mL
Standard Deviation 1.987
|
—
|
|
Cmax IV
4-Hydroxy Atorvastatin
|
0.24 mg/mL
Standard Deviation 0
|
0.30 mg/mL
Standard Deviation 0.163
|
0.75 mg/mL
Standard Deviation 0.370
|
—
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The time to maximum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
Tmax IV
Atorvastatin
|
0.08 hours
Interval 0.0 to 0.5
|
0.08 hours
Interval 0.0 to 0.5
|
0.15 hours
Interval 0.1 to 0.2
|
—
|
|
Tmax IV
2-Hydroxy Atorvastatin
|
6.00 hours
Interval 6.0 to 8.0
|
6.0 hours
Interval 2.0 to 8.0
|
5.00 hours
Interval 4.0 to 6.0
|
—
|
|
Tmax IV
4-Hydroxy Atorvastatin
|
0.08 hours
Interval 0.0 to 0.1
|
6.0 hours
Interval 0.0 to 8.0
|
8.0 hours
Interval 8.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
AUC 0-24
Atorvastatin
|
72.12 ng*hr/mL
Standard Deviation 31.216
|
137.04 ng*hr/mL
Standard Deviation 134.608
|
212.00 ng*hr/mL
Standard Deviation 89.095
|
—
|
|
AUC 0-24
2-Hydroxy Atorvastatin
|
3.35 ng*hr/mL
Standard Deviation 2.603
|
16.76 ng*hr/mL
Standard Deviation 6.283
|
49.20 ng*hr/mL
Standard Deviation 26.698
|
—
|
|
AUC 0-24
4-Hydroxy Atorvastatin
|
NA ng*hr/mL
Standard Deviation NA
Values are below the level of detection
|
5.45 ng*hr/mL
Standard Deviation 3.691
|
12.65 ng*hr/mL
Standard Deviation 5.303
|
—
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
AUC Inf
|
72.19 ng*hr/mL
Standard Deviation 31.196
|
167.32 ng*hr/mL
Standard Deviation 138.099
|
217.00 ng*hr/mL
Standard Deviation 89.095
|
—
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
VDss
|
71.86 liter
Standard Deviation 81.475
|
135.53 liter
Standard Deviation 145.579
|
182.85 liter
Standard Deviation 140.219
|
—
|
SECONDARY outcome
Timeframe: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dosePopulation: Pharmacokinetic Population: All subjects in the Efficacy Population who had no major protocol deviations and who had sufficient plasma atorvastatin concentration data for reliable estimates of the key PK variables for each of the four baseline cohorts.
The half-life of atorvastatin following an intravenous injection to a patient at a steady state.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 2
n=13 Participants
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 3
n=2 Participants
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin receiving either IV or SC study drug
|
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin receiving either SC study drug
|
|---|---|---|---|---|
|
t 1/2
|
4.79 hours
Standard Deviation 4.311
|
6.22 hours
Standard Deviation 1.884
|
6.38 hours
Standard Deviation 0.085
|
—
|
Adverse Events
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=14 participants at risk
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
|
Cohort 2
n=14 participants at risk
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
|
Cohort 3
n=2 participants at risk
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
|
Cohort 4
n=10 participants at risk
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days
Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Number of events 1 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
0.00%
0/10 • 15 days
|
|
General disorders
Injection site pain
|
0.00%
0/14 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
10.0%
1/10 • Number of events 1 • 15 days
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
0.00%
0/10 • 15 days
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
10.0%
1/10 • Number of events 1 • 15 days
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/14 • 15 days
|
7.1%
1/14 • Number of events 1 • 15 days
|
0.00%
0/2 • 15 days
|
0.00%
0/10 • 15 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
10.0%
1/10 • Number of events 1 • 15 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
10.0%
1/10 • Number of events 1 • 15 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
0.00%
0/10 • 15 days
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • 15 days
|
0.00%
0/14 • 15 days
|
0.00%
0/2 • 15 days
|
0.00%
0/10 • 15 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • 15 days
|
0.00%
0/14 • 15 days
|
50.0%
1/2 • Number of events 1 • 15 days
|
0.00%
0/10 • 15 days
|
Additional Information
Senior Manager, Clinical Development
Cumberland Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place