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Trial record 7 of 137 for:    Lupus AND (woman OR women OR female)

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00739050
Recruitment Status : Terminated
First Posted : August 21, 2008
Results First Posted : December 16, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: simvastatin
Drug: Comparator: Placebo
Enrollment 4

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 Details  
Arm/Group Title Simvastatin Placebo
Hide 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 [1] 0
Not Completed 1 0
[1]
These 3 patients completing treatment did not complete the required procedures during the trial.
Arm/Group Title All Participants
Hide 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 Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Total Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 4 participants
176.67  (28.50)
[1]
Measure Description: N=3 (Completed Participants)
Low Density Lipoprotein Cholesterol (LDL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 4 participants
105  (23.64)
[1]
Measure Description: N=3 (Completed Participants)
High Density Lipoprotein Cholesterol (HDL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 4 participants
53  (10.15)
[1]
Measure Description: N=3 (Completed Participants)
1.Primary Outcome
Title Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Hide Description The study was terminated; no outcome measure data analyses were conducted.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
simvastatin 20 mg daily at nights for 12 weeks
Placebo daily at nights for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Total Cholesterol From Baseline at Week 12
Hide Description The study was terminated; no outcome measure data analyses were conducted.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
simvastatin 20 mg daily at nights for 12 weeks
Placebo daily at nights for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
Hide Description The study was terminated; no outcome measure data analyses were conducted.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
simvastatin 20 mg daily at nights for 12 weeks
Placebo daily at nights for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
Hide Description The study was terminated; no outcome measure data analyses were conducted.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
simvastatin 20 mg daily at nights for 12 weeks
Placebo daily at nights for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739050     History of Changes
Other Study ID Numbers: 0733-271
2008_021
First Submitted: August 19, 2008
First Posted: August 21, 2008
Results First Submitted: August 26, 2010
Results First Posted: December 16, 2010
Last Update Posted: May 5, 2017