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A Broken Pact With Researchers and Patients

Bruce M. Psaty, MD, PhD; Drummond Rennie, MD

JAMA. 2003;289:2128-2131.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

In this issue of THE JOURNAL, Black and colleagues¹ report the results of an aborted clinical trial. In the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) study, a large randomized double-blind equivalence trial with many strengths, the investigators compared a controlled-onset extended-release formulation of the calcium channel blocker verapamil with standard therapies (atenolol or hydrochlorothiazide) for hypertension. Randomization was stratified on type of standard care—diuretics or -blockers—with the result that there were, in effect, 2 parallel trials within CONVINCE, verapamil vs each of the other 2. When the rates of withdrawal from treatment were noted to be higher than expected, the sample size was increased from 15 000 to 16 600 with a new target of 2246 primary events, which included first myocardial infarction, stroke, or cardiovascular disease–related death.

The occurrence of the prespecified primary end point was 2% higher in patients . . . [Full Text of this Article]

Author Affiliations: Departments of Medicine, Epidemiology, and Health Services, Cardiovascular Health Research Unit, University of Washington, Seattle (Dr Psaty); and Institute for Health Policy Studies, University of California, San Francisco, and Deputy Editor, JAMA, Chicago, Ill (Dr Rennie).

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