Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00739050
First received: August 19, 2008
Last updated: November 16, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: simvastatin Drug: Comparator: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The study was terminated; no outcome measure data analyses were conducted.
Secondary Outcome Measures:
- Change in Total Cholesterol From Baseline at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The study was terminated; no outcome measure data analyses were conducted.
- Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The study was terminated; no outcome measure data analyses were conducted.
- Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The study was terminated; no outcome measure data analyses were conducted.
| Enrollment: | 4 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: Drug
|
Drug: simvastatin
simvastatin 20mg daily at nights for 12 weeks. Tablets
Other Names:
|
|
Placebo Comparator: 2
Arm 2: Placebo
|
Drug: Comparator: Placebo
placebo daily at nights for 12 weeks. Tablets
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female Patients Over 18 Years Old
- Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
- Signed Informed Consent Form (ICF)
Exclusion Criteria:
- Patients With LDL-C Below 90 mg/dL
- Pregnant Or Breast Feeding
- Diabetes Mellitus
- Or Any Clinically Relevant Organ Disfunction
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00739050 History of Changes |
| Other Study ID Numbers: | MK-0733-271, 2008_021 |
| Study First Received: | August 19, 2008 |
| Results First Received: | August 26, 2010 |
| Last Updated: | November 16, 2010 |
| Health Authority: | Mexico: Ministry of Health |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Simvastatin Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013