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

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dyslipidemias; Hypercholesterolemia

Treatments: Drug: Atorvastatin injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611010

CPI-1103-002

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Treatment:

Drug: Atorvastatin injection

Cohort 2

Experimental group

Description:

Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Treatment:

Drug: Atorvastatin injection

Cohort 3

Experimental group

Description:

Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Treatment:

Drug: Atorvastatin injection

Cohort 4

Experimental group

Description:

Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days

Treatment:

Drug: Atorvastatin injection