Mobile

A 12-week Open-Label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to compare the Efficacy and Safety of rosuvastatin (CRESTOR) 10 mg and 20 mg in Combination with Ezetimibe 10 mg and Siv...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002810-20

A 12-week Open-Label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to compare the Efficacy and Safety of rosuvastatin (CRESTOR) 10 mg and 20 mg in Combination with Ezetimibe 10 mg and Sivastatin 40 mg and 80 mg in Combination with Ezetimibe 10 mg (fixed dose combination) in Patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20% (GRAVITY)

Femme et Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

The primary objective of this study is to evaluate the LDL-C lowering efficacy of rosuvastatin 10 mg and 20 mg in combination with ezetimibe relative to that of simvastatin in a fixed dose combination with ezetimibe. This objective has 3 specific components: 1. Percentage change from baseline in LDL-C for rosuvastatin 20mg in combination with ezetimibe 10mg vs simvastatin 40mg in combination with ezetimibe 10mg after 6 weeks combination therapy (mean value of 4 and 6 weeks of combination therapy will be used) 2. Percentage change from baseline in LDL-C for rosuvastatin 10mg in combination with ezetimibe 10mg vs simvastatin 40mg in combination with ezetimibe 10mg after 6 weeks combination therapy (mean value of 4 and 6 weeks of combination therapy will be used) 3. Percentage change from baseline in LDL-C for rosuvastatin 20mg in combination with ezetimibe 10mg vs simvastatin 80mg in combination with ezetimibe 10mg after 6 weeks combination therapy

Critère d'inclusion

  • Dyslipidemia - Expert groups have identified low-density lipoprotein cholesterol (LDL-C) as the primary target for cholesterol lowering therapy because it is strongly associated with coronary heart disease (CHD) risk but, more importantly, clinical studies document that lowering LDL-C reduces the risk for major CHD events (Expert Panel NCEP ATP III 2001: De Backer et al 2003; American Heart Association (AHA)/American College of Cardiology (ACC): Smith et al 2006)

Liens