SWITCH

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

• IRAS ID

  54014

• Contact name

  Christopher Paul Fletcher

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2009-015247-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  High blood cholesterol is associated with a number of health problems including a greater chance of getting cardiovascular diseases, such as heart disease and stroke. Therapies which lower blood cholesterol have been shown to reduce cardiovascular risk.Two of the types of drugs which can be prescribed to reduce blood cholesterol are ??statins,? such as atorvastatin or rosuvastatin, and cholesterol absorption inhibitors, such as ezetimibe. The combination of these 2 types of cholesterol lowering drugs may provide superior cholesterol lowering than the standard statin monotherapy. This study will evaluate the efficacy and safety of switching to co-administration of ezetimibe and atorvastatin compared with doubling the dose of atorvastatin or switching to rosuvastatin in patients with primary hypercholesterolaemia and high cardiovascular risk who are not adequately controlled with atorvastatin 10 mg. Ezetimibe and atorvastatin are each available by prescription to treat high blood cholesterol levels. Rosuvastatin is another drug also available by prescription to treat high blood cholesterol levels.This study will enrol male and female patients aged 18 to 79 years old diagnosed with primary hypercholesterolaemia and high cardiovascular risk. After a 5-week Run-In period (during which patients will be on an open-label cholesterol lowering treatment with atorvastatin 10 mg), patients meeting lipid eligibility criteria will be randomised to one of six double blinded treatment sequences for the next 6 or 12 weeks (depending if the patient qualifies for treatment phase II based on treatment sequence to which patient was randomised to and/or meeting lipid criteria). Participants who complete both treatment phases will attend 8 clinic visits over an 18 week period. A safety follow-up telephone call will be conducted 2 weeks after study drug treatment is completed. The study will recruit 1508 patients in 30 countries. Merck Sharp & Dohme Corp. is sponsoring this study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/51

• Date of REC Opinion

  11 Oct 2010

• REC opinion

  Further Information Favourable Opinion