Systemic Lupus Erythematosus
Conditions
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.
Interventions
DRUGsimvastatin
simvastatin 20mg daily at nights for 12 weeks. Tablets
DRUGComparator: Placebo
placebo daily at nights for 12 weeks. Tablets
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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
Participants by arm
| Arm | Count |
|---|---|
| All Participants 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) | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| High Density Lipoprotein Cholesterol (HDL-C) | 53 mg/dL STANDARD_DEVIATION 10.15 |
| Low Density Lipoprotein Cholesterol (LDL-C) | 105 mg/dL STANDARD_DEVIATION 23.64 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
| Total Cholesterol | 176.67 mg/dL STANDARD_DEVIATION 28.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
The study was terminated; no outcome measure data analyses were conducted.
Time frame: Baseline and 12 weeks
Population: 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.
Secondary
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
The study was terminated; no outcome measure data analyses were conducted.
Time frame: Baseline and 12 weeks
Population: 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.
Secondary
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
The study was terminated; no outcome measure data analyses were conducted.
Time frame: Baseline and 12 weeks
Population: 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.
Secondary
Change in Total Cholesterol From Baseline at Week 12
The study was terminated; no outcome measure data analyses were conducted.
Time frame: Baseline and 12 weeks
Population: 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.