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

• Status: Completed
• Trial end date: 2020-02-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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