Raloxifene Use for The Heart
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Breast Neoplasms
Intervention: raloxifene (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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 Fractures Venous thromboembolism.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women with established coronary heart disease or at risk for a major
coronary event.
Exclusion Criteria:
- Postmenopausal symptoms that required estrogen replacement therapy.
- Suspected or known history of breast or endometrial carcinoma.
- Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal
vein thrombosis.
- New York Heart Association classes III or IV heart failure.
Locations and Contacts
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
Additional Information
Related publications: Wenger NK, Barrett-Connor E, Collins P, Grady D, Kornitzer M, Mosca L, Sashegyi A, Baygani SK, Anderson PW, Moscarelli E. Baseline characteristics of participants in the Raloxifene Use for The Heart (RUTH) trial. Am J Cardiol. 2002 Dec 1;90(11):1204-10. Mosca L, Barrett-Connor E, Wenger NK, Collins P, Grady D, Kornitzer M, Moscarelli E, Paul S, Wright TJ, Helterbrand JD, Anderson PW. Design and methods of the Raloxifene Use for The Heart (RUTH) study. Am J Cardiol. 2001 Aug 15;88(4):392-5.
Starting date: June 1998
Ending date: November 2005
Last updated: January 24, 2007
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