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
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