Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Sanofi
Study ID
NCT01288469
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    One subcutaneous (SC) injection in the abdomen only.
  • Placebo (for alirocumab) — DRUG
    One SC injection in the abdomen only.
  • Atorvastatin — DRUG
    Over-encapsulated tablet orally once daily in the evening with dinner.
  • Placebo (for atorvastatin) — DRUG
    One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.

Study Details

Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.

Key Dates

Start date
Jan 31, 2011
Status verified
Jan 2015
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo + Atorvastatin 80 mg
    Placebo (for alirocumab) subcutaneous (SC) administration every 2 weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
  • Experimental: Alirocumab + Atorvastatin 10 mg
    Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
  • Experimental: Alirocumab + Atorvastatin 80 mg
    Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis [ Time Frame: From Baseline to Week 8 (LOCF) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840616MesaArizona85206-
Investigational Site Number 840601TucsonArizona85710-
Investigational Site Number 840610Los AngelesCalifornia90057-
Investigational Site Number 840608Newport BeachCalifornia92660-
Investigational Site Number 840603DoralFlorida33166-
Investigational Site Number 840611JacksonvilleFlorida32223-
Investigational Site Number 840618JupiterFlorida33458-
Investigational Site Number 840612MiamiFlorida33138-
Investigational Site Number 840614MiamiFlorida33138-
Investigational Site Number 840607St. PetersburgFlorida33609-
Investigational Site Number 840605ChicagoIllinois60610-
Investigational Site Number 840619ChicagoIllinois60610-
Investigational Site Number 840604EdisonNew Jersey08817-
Investigational Site Number 840606RochesterNew York14609-
Investigational Site Number 840615CincinnatiOhio45219-
Investigational Site Number 840617CincinnatiOhio45219-
Investigational Site Number 840602EugeneOregon97404-
Investigational Site Number 840621RichmondVirginia23227-
Investigational Site Number 840609OlympiaWashington98502-
Investigational Site Number 840613OregonWisconsin53575-

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