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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. Identifier: NCT00190593
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Breast Neoplasms Drug: raloxifene Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Raloxifene

Primary Outcome Measures :
  1. 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.
  2. Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.

Secondary Outcome Measures :
  1. After an expected 5 to 7.5 years of follow-up:
  2. Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
  3. All-cause hospitalization and mortality
  4. Non-coronary artery revascularization
  5. Non-traumatic lower extremity amputation
  6. Fractures
  7. Venous thromboembolism.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00190593

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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
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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
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00190593    
Other Study ID Numbers: 1865
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiovascular Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents