Raloxifene Use for The Heart - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190593

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases Breast Neoplasms	Drug: raloxifene Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Raloxifene hydrochloride Raloxifene

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	10000
Study Start Date:	June 1998
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190593

Locations

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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Publications:

Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK; Raloxifene Use for The Heart (RUTH) Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006 Jul 13;355(2):125-37.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Collins P, Mosca L, Geiger MJ, Grady D, Kornitzer M, Amewou-Atisso MG, Effron MB, Dowsett SA, Barrett-Connor E, Wenger NK. Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors. Circulation. 2009 Feb 24;119(7):922-30. Epub 2009 Feb 9.

Study ID Numbers:	1865, H3S-MC-GGIO
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00190593 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators

Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Raloxifene
Neoplasms by Site
Cardiovascular Diseases
Breast Diseases

ClinicalTrials.gov processed this record on March 18, 2010