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Raloxifene Use for The Heart

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190593
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Cardiovascular Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Raloxifene
Selective Estrogen Receptor Modulators
 Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 21, 2013