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King Pharmaceuticals Reports Efficacy of Altace 20mg And Efficacy,of a Combination of Altace 20mg And Hydrochlorothiazide 25mg For,24-hour Blood Pressure Control

ith two antihypertensive drugs, one of which is usually a thiazide diuretic. In the study, combining ALTACE 20mg with HCT 25mg was significantly better than monotherapy in achieving blood pressure control. Our results also show that the maximum approved dose of 20mg a day of ALTACE was well tolerated and showed significant reductions in systolic and diastolic blood pressure," said Dr. William B. White, Professor and Chief of Hypertension and Clinical Pharmacology at the University of Connecticut Health Center, and the study's lead investigator. "These data provide evidence that ALTACE 20mg monotherapy and the combination of ALTACE 20mg with HCT 25mg provide meaningful clinical blood pressure reductions and 24-hour control."

"We're excited about the results of the study," said Dr. Eric Carter, Chief Science Officer of King. "These data demonstrate the efficacy and tolerability benefits of 20mg of ALTACE, the maximum approved dose, and the benefits of 20mg of ALTACE combined with HCT 25mg for patients who require an antihypertensive agent as well as a diuretic. We plan to submit these data as part of a New Drug Application to the FDA later this year, a major milestone for King Pharmaceuticals."

About the Clinical Trial

The primary endpoint of the trial was designed to demonstrate that the reduction in DBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in patients taking either monotherapy alone. The trial met the primary endpoint in that DBP reduction is statistically superior (p less than 0.001) with the combination compared to either monotherapy. The DBP was reduced by 15.5 mmHg with the combination compared to 8.5 mmHg with HCT 25mg and 9.2 mmHg with ALTACE 20mg.

A secondary endpoint of the trial was designed to demonstrate that the reduction in SBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in p
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