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



Status:Recruiting
Conditions:High Cholesterol, High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:4/6/2019
Start Date:August 7, 2018
End Date:December 2020
Contact:Jerry Fox, DVM
Email:jfox@cumberlandpharma.com
Phone:6152550068

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Trial Summary
Trial Overview
Inclusion Criteria

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

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


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
We found this trial at
1
site
Frontage Clinical Services Inc.
Secaucus, New Jersey 07094
Principal Investigator: Gregory Tracey, MD
Phone: 201-416-7763
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mi
from
Secaucus, NJ
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