Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
- Conditions
- HypercholesterolemiaDyslipidemias
- Interventions
- Registration Number
- NCT03611010
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
- Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.
- History of myopathy or rhabdomyolysis
- Liver disease including current biliary disorders
- Positive for HIV, Hepatitis B or Hepatitis C Virus
- Abuse of alcohol or non-prescribed drugs
- Unstable angina or arrhythmias or a cardiac event in the previous three months
- hypothyroidism, diabetes, or hypertension that is not under control
- pregnant or plans to be pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 4 Atorvastatin injection Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days Cohort 1 Atorvastatin injection Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days Cohort 2 Atorvastatin injection Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days Cohort 3 Atorvastatin injection Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
- Primary Outcome Measures
Name Time Method Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C Baseline, 15 Days 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.
- Secondary Outcome Measures
Name Time Method Tmax IV 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose 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.
AUC 0-24 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
AUC Inf 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.
VDss 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.
t 1/2 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose The half-life of atorvastatin following an intravenous injection to a patient at a steady state.
Change in Baseline LDL-C Concentration Baseline, 15 days Mean change in LDL-C (mg/dL) from baseline at Day 15
Cmax IV 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C Baseline, 15 Days 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.
Trial Locations
- Locations (1)
Frontage Clinical Services
🇺🇸Secaucus, New Jersey, United States