Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00532246
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Post-Menopausal |
Drug: raloxifene Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Study of Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene HCl or Placebo |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Raloxifene hydrochloride
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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:
- 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:
- 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.
- All enrolled patients, regardless of lipid lowering drug exposure or compliance with study drug while in CORE
- All enrolled patients who were at least 80% compliant with study drug while in CORE, regardless of use of lipid lowering therapy
| Enrollment: | 147 |
| Study Start Date: | March 2003 |
| Study Completion Date: | August 2003 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
raloxifene
|
Drug: raloxifene
Other Name: LY139481
|
|
Placebo Comparator: B
placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532246
Locations
| United States, California | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00532246 History of Changes |
| Other Study ID Numbers: | 8135, H3S-MC-GGLE |
| Study First Received: | September 18, 2007 |
| Last Updated: | September 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal 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