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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611010
• Other study ID #: CPI-1103-002
• Status: Completed
• Phase: Phase 2
• Start date: August 7, 2018
• Est. completion date: February 24, 2020

Study information

• Verified date: May 2022
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 24, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
United States	Frontage Clinical Services	Secaucus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C	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.	Baseline, 15 Days
Secondary	Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C	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.	Baseline, 15 Days
Secondary	Change in Baseline LDL-C Concentration	Mean change in LDL-C (mg/dL) from baseline at Day 15	Baseline, 15 days
Secondary	Cmax IV	The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Secondary	Tmax IV	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.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Secondary	AUC 0-24	The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Secondary	AUC Inf	The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Secondary	VDss	The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Secondary	t 1/2	The half-life of atorvastatin following an intravenous injection to a patient at a steady state.	3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose