Phase II, Dose-ranging Study to Evaluate the Efficacy Dose Response and Pharmacokinetics of Intravenous Atorvastatin in Hypercholesterolemic Patients Previously Controlled With Oral Atorvastatin
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cohort 1
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Intervention: Atorvastatin injection (Drug)
Cohort 2
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Intervention: Atorvastatin injection (Drug)
Cohort 3
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Intervention: Atorvastatin injection (Drug)
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days
Intervention: Atorvastatin injection (Drug)
Outcomes
Primary Outcomes
Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C
Time Frame: 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 Outcomes
- Tmax IV(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- AUC 0-24(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- AUC Inf(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- VDss(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- t 1/2(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- Change in Baseline LDL-C Concentration(Baseline, 15 days)
- Cmax IV(3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose)
- Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C(Baseline, 15 Days)