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

Completed · Phase 2

Conditions studied: Hypercholesterolemia, Dyslipidemias

In brief

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

Key facts

Study ID

NCT03611010

Run by

Cumberland Pharmaceuticals

People needed

40

Starts

2018-08-07

Expected to finish

2020-02-24

Last updated by the study team

2022-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Frontage Clinical Services — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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