Raloxifene Use for The Heart
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00190593|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Breast Neoplasms||Drug: raloxifene Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||10000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events|
|Study Start Date :||June 1998|
|Study Completion Date :||November 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|