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Biotech / Medical : Human Genome Sciences, Inc. (HGSI)
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To: Steven Rachbach who wrote (1108)8/28/2009 7:55:38 AM
From: kenhott   of 1127
 
The interim "independent analyses" will most likely not provide unblinded data to the company, being mostly safety in nature. That is the way I read the PR.

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About STABILITY and the Phase III programme

In STABILITY, men and women with chronic CHD and receiving standard of care will be randomised 1:1 to once-daily treatment with darapladib or placebo. The duration of the study will be determined by the rate of first occurrence of events that comprise the primary endpoint of MACE. The study will be stopped when approximately 1500 reports of first occurrence of MACE have occurred - estimated to be approximately three years - with interim independent analyses planned.

The study’s secondary objectives are to evaluate the efficacy of darapladib on major and total coronary events, including CHD death, non-fatal heart attack, urgent and non-urgent coronary revascularisation, or hospitalisation for unstable angina, individual components of MACE and all-cause mortality. Additional safety and efficacy data will also be collected. Pre-specified sub-studies will include 24-hour ambulatory blood pressure monitoring, progression of protein in urine, changes in cognitive function and pharmacokinetic analyses.

GSK is also planning to initiate another large event-driven trial with darapladib in late 2009 in a post-ACS patient population. ACS represents a spectrum of clinical presentations (unstable angina, non-ST segment elevation MI, ST segment elevation MI) that are associated with an increased risk of CV death, non-fatal MI and recurrent hospital admissions for refractory myocardial ischemia.
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