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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_021 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: Drug |
|
| 2 | Placebo Comparator | Arm 2: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin | Drug | simvastatin 20mg daily at nights for 12 weeks. Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol From Baseline at Week 12 | The study was terminated; no outcome measure data analyses were conducted. | Baseline and 12 weeks |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin | simvastatin 20 mg daily at nights for 12 weeks |
| FG001 | Placebo | Placebo daily at nights for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. | The study was terminated; no outcome measure data analyses were conducted. | 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. | Posted | Baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin | simvastatin 20 mg daily at nights for 12 weeks |
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The Investigator was not able to recruit the required patients and was not able to get the necessary equipment. The protocol was terminated for Administrative Reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Comparator: Placebo | Drug | placebo daily at nights for 12 weeks. Tablets |
|
The study was terminated; no outcome measure data analyses were conducted.
| Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Total Cholesterol | N=3 (Completed Participants) | Mean | Standard Deviation | mg/dL |
|
| Low Density Lipoprotein Cholesterol (LDL-C) | N=3 (Completed Participants) | Mean | Standard Deviation | mg/dL |
|
| High Density Lipoprotein Cholesterol (HDL-C) | N=3 (Completed Participants) | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Change in Total Cholesterol From Baseline at Week 12 | The study was terminated; no outcome measure data analyses were conducted. | 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. | Posted | Baseline and 12 weeks |
|
|
| 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. | 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. | Posted | Baseline and 12 weeks |
|
|
| 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. | 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. | Posted | Baseline and 12 weeks |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo | Placebo daily at nights for 12 weeks | 0 | 0 | 0 | 0 |
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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |