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OpenTrials
Completed

NCT Number: NCT03611010

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

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Frontage Clinical Services

Secaucus, New Jersey, 07094, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin injection

Drug

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

Primary outcomes

  1. 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

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

    Time frame: Baseline, 15 Days

    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.

  2. Change in Baseline LDL-C Concentration

    Time frame: Baseline, 15 days

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

  3. Cmax IV

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

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

  4. Tmax IV

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

    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.

  5. AUC 0-24

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

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

  6. AUC Inf

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

    The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.

  7. VDss

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

    The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.

  8. t 1/2

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

    The half-life of atorvastatin following an intravenous injection to a patient at a steady state.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

Phase II, Dose-ranging Study to Evaluate the Efficacy Dose Response and Pharmacokinetics of Intravenous Atorvastatin in Hypercholesterolemic Patients Previously Controlled With Oral Atorvastatin

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2018
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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