CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 299 enrolled
Drug / intervention
Bococizumab 150mg +3 morebiological
Likely dose
Bococizumab 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02458287
NCT02458287Phase 3Completed
CompareCT.gov

A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia

Pfizer·interventional·Posted Jun 1, 2015·Updated Dec 19, 2017

In Brief

A Phase 3 clinical trial evaluating Bococizumab 150mg, Bococizumab 75mg, and 2 other interventions for Hyperlipidemia. Completed, enrolled 299 participants across 30 sites.

Detailed Summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 1, 2015
Enrollment StartJun 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.1 years ago

Interventions

Bococizumab 150mgbiological

Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.

Bococizumab 75mgbiological

Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.

Bococizumab 150mg placebobiological

Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.

Bococizumab 75mg placebobiological

Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.