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Trial record 7 of 133 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Simvastatin simvastatin 20 mg daily at nights for 12 weeks
Placebo Placebo daily at nights for 12 weeks

Participant Flow:   Overall Study
    Simvastatin   Placebo
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 
Total Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 176.67  (28.50) 
[1] N=3 (Completed Participants)
Low Density Lipoprotein Cholesterol (LDL-C) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 105  (23.64) 
[1] N=3 (Completed Participants)
High Density Lipoprotein Cholesterol (HDL-C) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 53  (10.15) 
[1] N=3 (Completed Participants)


  Outcome Measures

1.  Primary:   Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Change in Total Cholesterol From Baseline at Week 12   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



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