Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. [Baseline and 12 weeks]
The study was terminated; no outcome measure data analyses were conducted.
Secondary Outcome Measures
- Change in Total Cholesterol From Baseline at Week 12 [Baseline and 12 weeks]
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 [Baseline and 12 weeks]
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 [Baseline and 12 weeks]
The study was terminated; no outcome measure data analyses were conducted.
Eligibility Criteria
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
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0733-271
- 2008_021
Study Results
Participant Flow
Recruitment Details | First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons |
---|---|
Pre-assignment Detail |
Arm/Group Title | Simvastatin | Placebo |
---|---|---|
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks |
Period Title: Overall Study | ||
STARTED | 4 | 0 |
COMPLETED | 3 | 0 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | All Randomized patients. Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C) |
Overall Participants | 4 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
4
100%
|
>=65 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
4
100%
|
Male |
0
0%
|
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mg/dL] |
176.67
(28.50)
|
Low Density Lipoprotein Cholesterol (LDL-C) (mg/dL) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mg/dL] |
105
(23.64)
|
High Density Lipoprotein Cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mg/dL] |
53
(10.15)
|
Outcome Measures
Title | Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. |
---|---|
Description | The study was terminated; no outcome measure data analyses were conducted. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment. |
Arm/Group Title | Simvastatin | Placebo |
---|---|---|
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks |
Measure Participants | 0 | 0 |
Title | Change in Total Cholesterol From Baseline at Week 12 |
---|---|
Description | The study was terminated; no outcome measure data analyses were conducted. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment. |
Arm/Group Title | Simvastatin | Placebo |
---|---|---|
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks |
Measure Participants | 0 | 0 |
Title | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment |
---|---|
Description | The study was terminated; no outcome measure data analyses were conducted. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment. |
Arm/Group Title | Simvastatin | Placebo |
---|---|---|
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks |
Measure Participants | 0 | 0 |
Title | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment |
---|---|
Description | The study was terminated; no outcome measure data analyses were conducted. |
Time Frame | Baseline and 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment. |
Arm/Group Title | Simvastatin | Placebo |
---|---|---|
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Simvastatin | Placebo | ||
Arm/Group Description | simvastatin 20 mg daily at nights for 12 weeks | Placebo daily at nights for 12 weeks | ||
All Cause Mortality |
||||
Simvastatin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Simvastatin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
Simvastatin | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- 0733-271
- 2008_021