Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/8/2019 |
| Start Date: | January 24, 2013 |
A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab
every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from
baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable
to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)
reductase inhibitors).
every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from
baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable
to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)
reductase inhibitors).
Inclusion Criteria:
- Male or female ≥ 18 to ≤ 80 years of age
- Not on a statin or on a low dose statin with stable dose for at least 4 weeks
- History of intolerance to at least 2 statins
- Subject not at LDL-C goal
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
- Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria:
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes, poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
We found this trial at
19
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials