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

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ClinicalTrials.gov Identifier: NCT03611010
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidemias Drug: Atorvastatin injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10 mg oral atorvastatin
Subjects taking 10 mg of oral atorvastatin daily at baseline will take titrated dose of atorvastatin injection.
Drug: Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection

Experimental: 20 mg oral atorvastatin
Subjects taking 20 mg of oral atorvastatin daily at baseline will take titrated dose of atorvastatin injection.
Drug: Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection

Experimental: 40 mg oral atorvastatin
Subjects taking 40 mg of oral atorvastatin daily at baseline will take titrated dose of atorvastatin injection.
Drug: Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection

Experimental: 80 mg oral atorvastatin
Subjects taking 80 mg of oral atorvastatin daily at baseline will take titrated dose of atorvastatin injection.
Drug: Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection




Primary Outcome Measures :
  1. Efficacy, Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 15 Days ]
    At least 11 of 13 subjects in a cohort that maintain LDL-C not more than 125% of their baseline level.


Secondary Outcome Measures :
  1. Efficacy, High -density lipoprotein cholesterol (HDL-C) [ Time Frame: 15 Days ]
    At least 11 of 13 subjects in a cohort that maintain HDL-C not more than 125% of their baseline level.

  2. Mean change, LDL-C [ Time Frame: 15 days ]
    The mean change in LDL-C from baseline to end of treatment across the cohort

  3. Cmax IV [ Time Frame: 24 hours ]
    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. AUCinf IV [ Time Frame: 24 hours ]
    Area under the curve to infinity of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  5. AUC0-24 IV [ Time Frame: 24 hours ]
    Area under the curve from administration to Hour 24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  6. T-1/2 IV [ Time Frame: 24 hours ]
    Elimination serum half-life of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  7. VDss IV [ Time Frame: 24 hours ]
    Volume of distribution of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  8. Kel IV [ Time Frame: 24 hours ]
    Elimination rate constant for atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  9. Cl IV [ Time Frame: 24 hours ]
    Plasma clearance calculated for atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.

  10. Cmax SC [ Time Frame: 24 hours ]
    Maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  11. AUCinf SC [ Time Frame: 24 hours ]
    Area under the curve to infinity of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  12. T-1/2 SC [ Time Frame: 24 hours ]
    Elimination serum half-life of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  13. VDss SC [ Time Frame: 24 hours ]
    Volume of distribution of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  14. Kel SC [ Time Frame: 24 hours ]
    Elimination rate constant of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  15. Cl/F SC [ Time Frame: 24 hours ]
    Apparent clearance of atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.

  16. Cl SC [ Time Frame: 24 hours ]
    Plasma clearance calculated for atorvastatin and the 2- and 4-hydroxy active metabolites following a single subcutaneous injection.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611010


Contacts
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Contact: Jerry Fox, DVM 6152550068 jfox@cumberlandpharma.com

Locations
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United States, New Jersey
Frontage Clinical Services Recruiting
Secaucus, New Jersey, United States, 07094
Contact: Dina Christodoro    201-416-7763    dchristodoro@frontagelab.com   
Principal Investigator: Gregory Tracey, MD         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Principal Investigator: Gregory Tracey, MD Frontage Lab

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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03611010     History of Changes
Other Study ID Numbers: CPI-1103-002
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors