AstraZeneca has unveiled a phase III study to assess the efficacy of its Crestor® (rosuvastatin) statin against a generic competitor.
The phase IIIb trial, dubbed “Gravity” by the company, is a 12-week open-label randomised parallel-group multicentre venture involving 800 patients.
It will compare Crestor in 10mg and 20mg doses in combination with 10mg of ezetimibe, against simvastatin in 40mg and 80mg doses alongside 10mg of ezetimibe in patients with hypercholesterolaemia and coronary heart disease (CHD).
Ezetimibe is a cholesterol absorption inhibitor, and the study is AstraZeneca’s first head-to-head comparison of Crestor/ezetimibe with simvastatin/ezetimibe.
The results are due in 2009.
Elisabeth Björk, global medical science director for Crestor, said: “Gravity will, for the first time, examine the effects of adding ezetimibe to low-dose Crestor and to simvastatin in a head-to-head clinical trial setting, to see which of these treatment options achieves the greatest LDL-C lowering benefits.
“We expect these results to firmly establish Crestor as the best statin upon which to base any combination therapy for patients with dyslipidaemia.”
Gravity is part of AstraZeneca’s “Galaxy” clinical trials to address unanswered questions in statin research, and to investigate the impact of Crestor on cardiovascular risk reduction.
Currently, more than 69,300 patients have been recruited from 55 countries worldwide to participate in the programme.
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