Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
NCT ID: NCT03611010
Last Updated: 2022-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2018-08-07
2020-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Cohort 2
Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Cohort 3
Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days
Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Cohort 4
Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days
Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Interventions
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Atorvastatin injection
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Eligibility Criteria
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Inclusion Criteria
* Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Tracey, MD
Role: PRINCIPAL_INVESTIGATOR
Frontage Lab
Locations
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Frontage Clinical Services
Secaucus, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CPI-1103-002
Identifier Type: -
Identifier Source: org_study_id
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