Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

Plain-language summary

This study examined the drug Bococizumab and its pre-filled pen autoinjector for efficacy, safety and actual use compared with placebo in people with hyperlipidemia or dyslipidemia. It included people taking a statin whose LDL cholesterol was above a certain level. It was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Pfizer

Intervention

Bococizumab 150mg, Bococizumab 75mg, Bococizumab 150mg placebo, Bococizumab 75mg placebo

Start date

6/1/2015

Estimated completion

2/1/2016

Countries

United States

Related genes

Locations

• Chandler, United States
• Lincoln, United States
• Los Angeles, United States
• Northridge, United States
• Sacramento, United States
• Walnut Creek, United States
• Atlantis, United States
• Coral Gables, United States
• Fort Lauderdale, United States
• Miami, United States
• Miami, United States
• Pembroke Pines, United States
• Stockbridge, United States
• Woodstock, United States
• Woodstock, United States
• Meridian, United States
• Evanston, United States
• Indianapolis, United States
• Valparaiso, United States
• Louisville, United States
• Metairie, United States
• Greensboro, United States
• Cincinnati, United States
• Mt. Pleasant, United States
• Summerville, United States
• Houston, United States
• Hopewell, United States
• Manassas, United States
• Richmond, United States
• Renton, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Treated with a statin - Fasting LDL-C \>=70mg/dL and triglycerides \<=400mg/dL

Exclusion Criteria:

* Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension