Raloxifene Use for The Heart
The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events|
- Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.
- Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
- After an expected 5 to 7.5 years of follow-up:
- Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
- All-cause hospitalization and mortality
- Non-coronary artery revascularization
- Non-traumatic lower extremity amputation
- Venous thromboembolism.
|Study Start Date:||June 1998|
|Estimated Study Completion Date:||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190593
|United States, Minnesota|
|For additonal information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician|
|Minneapolis, Minnesota, United States|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|