BioCentury
ARTICLE | Clinical News

Protara data

May 1, 1995 7:00 AM UTC

GNSA (San Diego) reported final analysis of the confirmatory clinical trial in 2,700 patients, first announced in October 1994, which found no significant difference between treated and control groups for primary and secondary endpoints. Meta-analysis pooling data from five trials does show activity in the indication, the company said.

The rate of myocardial infarction (the primary endpoint) was 4 percent in placebo and 3.4 percent in the Protara-treated group. The treated group showed a 13 percent lower incidence of combined outcomes of infarction, stroke, and cardiac death. None of the changes were statistically significant. ...