Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients

Cumberland Pharmaceuticals40 enrolled

Overview

Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia Dyslipidemias

Interventions

Atorvastatin injectionDRUG

statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Frontage Clinical Services

Secaucus, New Jersey, United States

Outcomes

Primary Outcomes

Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C

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.

Time frame: Baseline, 15 Days

Secondary Outcomes

Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C

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.

Time frame: Baseline, 15 Days

Change in Baseline LDL-C Concentration

Mean change in LDL-C (mg/dL) from baseline at Day 15

Time frame: Baseline, 15 days

Cmax IV

The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

Tmax IV

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.

Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

AUC 0-24

The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

Data from ClinicalTrials.gov

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