Raloxifene Use for The Heart - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 24, 2007

Start Date ^ICMJE

June 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Raloxifene Use for The Heart

Official Title ^ICMJE

Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cardiovascular Diseases
Breast Neoplasms

Intervention ^ICMJE

Drug: raloxifene
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

10000

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00190593

Responsible Party

Study ID Numbers ^ICMJE

1865, H3S-MC-GGIO

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP