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Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Phase 2 trial testing Atorvastatin injection in Hypercholesterolemia in 40 participants. Completed in 24 February 2020.
| Lead sponsor | Cumberland Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 7 August 2018 |
| Primary completion | 17 February 2020 |
| Estimated completion | 24 February 2020 |
| Sites | 1 location across United States |
Cumberland Pharmaceuticals — full company profile →
Adults 18 to 65, any sex, with Hypercholesterolemia or Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 9 | |
| Cohort 2 | 9 | |
| Cohort 3 | 1 | |
| Cohort 4 | 7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 11 | |
| Cohort 2 | 13 | |
| Cohort 3 | 1 | |
| Cohort 4 | 9 |
Mean change in LDL-C (mg/dL) from baseline at Day 15
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 12.36 | ± 14.740 |
| Cohort 2 | 2.62 | ± 34.844 |
| Cohort 3 | 27.50 | ± 14.849 |
| Cohort 4 | 11.22 | ± 13.283 |
The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 284.33 | ± 189.540 |
| Cohort 2 | 830.34 | ± 1141.919 |
| Cohort 3 | 507.50 | ± 443.456 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0.40 | ± 0.87 |
| Cohort 2 | 1.23 | ± 0.450 |
| Cohort 3 | 3.23 | ± 1.987 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0.24 | ± 0 |
| Cohort 2 | 0.30 | ± 0.163 |
| Cohort 3 | 0.75 | ± 0.370 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0.08 | 0.0 – 0.5 |
| Cohort 2 | 0.08 | 0.0 – 0.5 |
| Cohort 3 | 0.15 | 0.1 – 0.2 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 6.00 | 6.0 – 8.0 |
| Cohort 2 | 6.0 | 2.0 – 8.0 |
| Cohort 3 | 5.00 | 4.0 – 6.0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0.08 | 0.0 – 0.1 |
| Cohort 2 | 6.0 | 0.0 – 8.0 |
| Cohort 3 | 8.0 | 8.0 – 8.0 |
The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 72.12 | ± 31.216 |
| Cohort 2 | 137.04 | ± 134.608 |
| Cohort 3 | 212.00 | ± 89.095 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 3.35 | ± 2.603 |
| Cohort 2 | 16.76 | ± 6.283 |
| Cohort 3 | 49.20 | ± 26.698 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | NA | ± NA |
| Cohort 2 | 5.45 | ± 3.691 |
| Cohort 3 | 12.65 | ± 5.303 |
The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 72.19 | ± 31.196 |
| Cohort 2 | 167.32 | ± 138.099 |
| Cohort 3 | 217.00 | ± 89.095 |
The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 71.86 | ± 81.475 |
| Cohort 2 | 135.53 | ± 145.579 |
| Cohort 3 | 182.85 | ± 140.219 |
The half-life of atorvastatin following an intravenous injection to a patient at a steady state.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 4.79 | ± 4.311 |
| Cohort 2 | 6.22 | ± 1.884 |
| Cohort 3 | 6.38 | ± 0.085 |
Time frame: 15 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — |
| Vision blurred | Eye disorders | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — |
| Viral infection | Infections and infestations | — | — | — | — |
| Lip injury | Injury, poisoning and procedural complications | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT03611010 adverse events section.
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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