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

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00739050

First received: August 19, 2008

Last updated: November 16, 2010

Last verified: November 2010

History of Changes

Results First Received: August 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Systemic Lupus Erythematosus
Interventions:	Drug: simvastatin Drug: Comparator: Placebo

Participant Flow

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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

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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
Number of Participants [units: participants]	4
Age [units: years]
<=18 years	0
Between 18 and 65 years	4
>=65 years	0
Gender [units: participants]
Female	4
Male	0
Total Cholesterol ^[1] [units: mg/dL] Mean ± Standard Deviation	176.67 ± 28.50
Low Density Lipoprotein Cholesterol (LDL-C) ^[1] [units: mg/dL] Mean ± Standard Deviation	105 ± 23.64
High Density Lipoprotein Cholesterol (HDL-C) ^[1] [units: mg/dL] Mean ± Standard Deviation	53 ± 10.15

[1]	N=3 (Completed Participants)

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

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

Other Adverse Events

	Simvastatin	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	0/4	0/0

More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00739050 History of Changes
Other Study ID Numbers:	MK-0733-271, 2008_021
Study First Received:	August 19, 2008
Results First Received:	August 26, 2010
Last Updated:	November 16, 2010
Health Authority:	Mexico: Ministry of Health

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