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


Phase 3
55 Years
N/A
Not Enrolling
Female
Cardiovascular Diseases, Breast Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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.

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

1865

NCT ID:

NCT00190593

Start Date:

June 1998

Completion Date:

November 2005

Related Keywords:

  • Cardiovascular Diseases
  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Cardiovascular Diseases

Name

Location

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 physicianMinneapolis, Minnesota