Status:
COMPLETED
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
Lead Sponsor:
Amgen
Conditions:
Hyperlipidemia
Mixed Dyslipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or en...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.
- Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL (inclusive) and on statin therapy.
- Other inclusion criteria may apply.
Exclusion
- Subject with current or prior history of statin intolerance
- Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
- Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
- Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
- History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
- Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
- Other exclusion criteria may apply.
Key Trial Info
Start Date :
August 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02275156
Start Date
August 19 2014
End Date
December 19 2014
Last Update
November 7 2022
Active Locations (1)
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1
Research Site
Denver, Colorado, United States, 80230