Hyperlipidaemia News

  • 22 May 2017
    Trial Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) ClinicalTrials.gov Identifier: NCT02585778 Aim To demonstrate the superiority of alirocumab in comparison with...
  • 16 October 2016
    Alirocumab Trial An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT02890992 Aim To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in...
  • 11 August 2016
    Trial ODYSSEY JAPAN Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily...
  • 21 July 2016
    Alirocumab Safety Alirocumab treatment was well tolerated; injection site reactions occurred in 3.8% of patients in the alirocumab group versus 2.1% on placebo. Trial ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab ClinicalTrials.gov Identifier: NCT01663402 Aim To test...
  • 11 July 2016
    Trial ODYSSEY DM-Dyslipidemia: Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidaemia ClinicalTrials.gov Identifier: NCT02642159 Aim To show the superiority of alirocumab versus usual care in the reduction of non-HDL-C in patients with type 2...
  • 11 July 2016
    Trial ODYSSEY APPRISE: Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies ClinicalTrials.gov Identifier: NCT02476006 Aim To assess efficacy and overall safety and tolerability of alirocumab in patients with...
  • 11 July 2016
    Trial ODYSSEY-NIPPON: Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin ClinicalTrials.gov Identifier: NCT02584504 Aim To evaluate the efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately...
  • 24 March 2016
    Trial Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE) Clinical Trials Number: NCT02326220 Aim to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in...
  • 26 May 2015
    Trial Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular [CV] Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) Aim To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk patients with hypercholesterolemia...
  • 26 May 2015
    Trial Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) Aim To evaluate the efficacy and safety or alirocumab as add-on to non-statin lipid modifying background therapy (ezetimibe or fenofibrate) or as monotherapy in comparison with placebo in patients with primary...
  • 26 May 2015
    Trial Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) Aim To determine if alirocumab is effective and safe compared with placebo, if used alone or added to current cholesterol-lowering medication Study...
  • 19 May 2015
    Trial Study of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (Odyssey Alternative) Aim To evaluate the efficacy and safety of alirocumab in patients with primary hypercholesterolaemia who are intolerant to statins Study...
  • 19 May 2015
    Trial Efficacy and safety of combining alirocumab with atorvastatin or rosuvastatin versus adding ezetimibe, doubling statin dose or switching statin therapy in high cardiovascular risk patients (ODYSSEY OPTIONS I and II) Aim To evaluate the efficacy and safety of alirocumab as add-on therapy to either atorvastatin (20-40 mg, OPTIONS I) or...
  • 19 May 2015
    Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY Combo I) Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL‑C) by alirocumab as add-on therapy to stable maximally tolerated daily...
  • 18 May 2015
    Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia (ODYSSEY MONO) ClinicalTrials.gov Identifier: NCT01644474 Primary aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in...
  • 18 May 2015
    Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)Clinical Trials Number: NCT01623115 Study of Alirocumab (REGN727/ SAR236553) in Patients With heFH (...
  • 18 May 2015
    Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY High FH) Aim To evaluate the effect of alirocumab on LDL cholesterol levels after 24 weeks of treatment in comparison with placebo (on top of lipid-modifying therapy...
  • 18 May 2015
    Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II) Aim To compare the efficacy [low-density lipoprotein cholesterol (LDL-C) lowering] and safety of alirocumab with ezetimibe, as add-on therapy to maximally tolerated...
  • 13 May 2014
    Trial Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH) Aim To report safety and efficacy data after 52 weeks of a 4- year extension to an earlier 12-week trial (R727-CL-1003) of alirocumab or placebo in patients with HeFH on statin ± ezetimibe Study design Phase 2 open-label treatment extension to 12-week...

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