Completed

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥100 mg/dL (≥2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy

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What is being tested

Placebo (for alirocumab)

+ Atorvastatin

+ Alirocumab

Drug
Who is being recruted

Hyperlipidemias+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 20 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorSanofi
Last updated: October 4, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.

NCT01812707
Principal SponsorSanofi
Last updated: October 4, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHypercholesterolemia

Criteria

Inclusion criteria : - Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit. OR - Participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy. Exclusion criteria: LDL-C <100 mg/dL (<2.59 mmol/L) at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening Participants with type 1 diabetes Participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.

Group II

Experimental
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Group III

Experimental
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Group IV

Placebo
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Investigational Site Number 392002

Koganeishi, JapanOpen Investigational Site Number 392002 in Google Maps

Investigational Site Number 392001

Shinjuku-Ku, Japan

Investigational Site Number 392003

Suita-Shi, Japan

Investigational Site Number 392004

Suita-Shi, Japan
Completed4 Study Centers