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Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo

NCT ID: NCT00532246

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-08-31

Brief Summary

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The purpose of this study is to measure carotid artery IMT at a single visit in a subset of women previously enrolled in the CORE (H3S-MC-GGJY) trial

Detailed Description

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Conditions

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Osteoporosis, Post-Menopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A

raloxifene

Group Type EXPERIMENTAL

raloxifene

Intervention Type DRUG

B

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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raloxifene

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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LY139481

Eligibility Criteria

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Inclusion Criteria

* Patients must have completed the Eli Lilly and Company clinical trial CORE (H3S-MC-GGJY) inclusive of visit 5, in one of the 9 participating study sites in California.
* Patients must have been dispensed study drug in the CORE trial (H3S-MC-GGJY).

Exclusion Criteria

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have previously withdrawn from this exploratory study or any other study investigating raloxifene
* Are employed by Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Eli Lilly and Company employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly and Company facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

La Jolla, California, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Menlo Park, California, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Oakland, California, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

San Diego, California, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Walnut Creek, California, United States

Site Status

Countries

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United States

Other Identifiers

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H3S-MC-GGLE

Identifier Type: -

Identifier Source: secondary_id

8135

Identifier Type: -

Identifier Source: org_study_id