CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

May 1, 2000

NDA 19-901/S-028 Altace (ramipril) for Significant reduction of mortality, myocardial infarction, stroke, revascularization procedures, and heart failure in high risk patients

Combined Medical & Statistical Review; Heart Outcomes Prevention Evaluation (HOPE) Study, Division of Cardio-Renal Drugs, FDA

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Altace (ramipril) Capsules, King Pharmaceuticals Inc.

Cover Letter and Table of Contents

Section I. The HOPE Study Briefing Documents

II. Draft labeling

III. HOPE Event Adjudication Definitions

IV. The HOPE Study Protocol