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AMG 145 is being developed for the treatment of hypercholesterolemia. The purpose of the study is to evaluate the safety and tolerability of multiple doses of AMG 145 when given as an add-on to stable statin therapy. The study hypotheses are that no significant safety issues will be identified following multiple SC doses of AMG 145 when administered as an add-on to stable statin therapy, and there will be a statistically significant decrease in LDL-C (low density lipoprotein cholesterol) levels following multiple SC doses of AMG 145 when administered as an add-on to stable statin therapy compared to placebo.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
AMG 145, Placebo
Published on BioPortfolio: 2014-08-27T03:13:20-0400
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The primary hypothesis is that both dosing regimens of SC evolocumab (AMG 145) in combination with statin therapy will be well tolerated and will result in greater reduction of LDL-C in di...
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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Common occlusive arterial disease which is caused by ATHEROSCLEROSIS. It is characterized by lesions in the innermost layer (ARTERIAL INTIMA) of arteries including the AORTA and its branches to the extremities. Risk factors include smoking, HYPERLIPIDEMIA, and HYPERTENSION.
A type of familial lipid metabolism disorder characterized by a variable pattern of elevated plasma CHOLESTEROL and/or TRIGLYCERIDES. Multiple genes on different chromosomes may be involved, such as the major late transcription factor (UPSTREAM STIMULATORY FACTORS) on CHROMOSOME 1.
Rare and often fatal drug complication which affects patients undergoing long-term treatment with high doses of PROPOFOL. It is characterized by METABOLIC ACIDOSIS; HYPERLIPIDEMIA; RHABDOMYOLYSIS; cardiovascular CIRCULATORY COLLAPSE; CARDIAC FAILURE; and KIDNEY FAILURE.
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