Trial Outcomes & Findings for Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED) (NCT NCT00739050)
NCT ID: NCT00739050
Last Updated: 2024-05-23
Results Overview
The study was terminated; no outcome measure data analyses were conducted.
TERMINATED
PHASE4
4 participants
Baseline and 12 weeks
2024-05-23
Participant Flow
First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons
Participant milestones
| Measure |
Simvastatin
simvastatin 20 mg daily at nights for 12 weeks
|
Placebo
Placebo daily at nights for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Baseline characteristics by cohort
| Measure |
All Participants
n=4 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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Total Cholesterol
|
176.67 mg/dL
STANDARD_DEVIATION 28.50 • n=99 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
|
105 mg/dL
STANDARD_DEVIATION 23.64 • n=99 Participants
|
|
High Density Lipoprotein Cholesterol (HDL-C)
|
53 mg/dL
STANDARD_DEVIATION 10.15 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
The study was terminated; no outcome measure data analyses were conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
The study was terminated; no outcome measure data analyses were conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
The study was terminated; no outcome measure data analyses were conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
The study was terminated; no outcome measure data analyses were conducted.
Outcome measures
Outcome data not reported
Adverse Events
Simvastatin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER