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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00532246
Collaborator
(none)
147
Enrollment
5
Locations
2
Arms
5
Duration (Months)
29.4
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Study of Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene HCl or Placebo
Study Start Date :
Mar 1, 2003
Actual Study Completion Date :
Aug 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

raloxifene

Drug: raloxifene
Other Names:
  • LY139481

    		•
    Placebo Comparator: B

    placebo

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Test the hypothesis that in postmenopausal women with osteoporosis who took lipid lowering meds for more than 6 months > 80% compliant with study drug during CORE trial, mean carotid IMT will be lower in patients treated with raloxifene than placebo []

    Secondary Outcome Measures

    1. To test the hypothesis that, in postmenopausal women with osteoporosis, mean carotid IMT will be significantly lower in patients treated with raloxifene as compared to mean carotid IMT in patients treated with placebo in the following: []

    2. All enrolled patients who have not been exposed to lipid lowering medication for more than 6 months while in the CORE trial, regardless of study drug compliance. []

    3. All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE []

    4. All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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
    2 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
    3 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
    4 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
    5 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

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00532246
    Other Study ID Numbers:
    • 8135
    • H3S-MC-GGLE
    First Posted:
    Sep 20, 2007
    Last Update Posted:
    Sep 20, 2007
    Last Verified:
    Sep 1, 2007
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Raloxifene Hydrochloride

    Study Results

    No Results Posted as of Sep 20, 2007