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

• Sponsor: Organon and Co (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00739050
• Collaborator: (none)
• Enrollment: 4
• Arms: 2
• Actual Duration (Months): 4.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: simvastatin; Drug: Comparator: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
• Actual Study Start Date: Sep 19, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Arm 1: Drug	Drug: simvastatin; simvastatin 20mg daily at nights for 12 weeks. Tablets; Other Names: Zocor MK0733
Placebo Comparator: 2 Arm 2: Placebo	Drug: Comparator: Placebo; placebo daily at nights for 12 weeks. Tablets

Outcome Measures

Primary Outcome Measures

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

   The study was terminated; no outcome measure data analyses were conducted.

Secondary Outcome Measures

1. Change in Total Cholesterol From Baseline at Week 12 [Baseline and 12 weeks]

   The study was terminated; no outcome measure data analyses were conducted.

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

   The study was terminated; no outcome measure data analyses were conducted.

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

   The study was terminated; no outcome measure data analyses were conducted.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female Patients Over 18 Years Old

• Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)

• Signed Informed Consent Form (ICF)

Exclusion Criteria:

• Patients With LDL-C Below 90 mg/dL

• Pregnant Or Breast Feeding

• Diabetes Mellitus

• Or Any Clinically Relevant Organ Disfunction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00739050
• Other Study ID Numbers: 0733-271; 2008_021
• First Posted: Aug 21, 2008
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Simvastatin

Study Results

Participant Flow

Recruitment Details	First patient enrolled (FPE): 19 Sept 2007; Last patient enrolled (LPE) 22 Oct 2007. The protocol was terminated for Administrative Reasons

Arm/Group Title	Simvastatin	Placebo
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	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	All Participants
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 Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 100%
Male	0 0%
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	176.67 (28.50)
Low Density Lipoprotein Cholesterol (LDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	105 (23.64)
High Density Lipoprotein Cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	53 (10.15)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Description	The study was terminated; no outcome measure data analyses were conducted.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

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
Arm/Group Description	simvastatin 20 mg daily at nights for 12 weeks	Placebo daily at nights for 12 weeks
Measure Participants	0	0

2. Secondary Outcome

Title	Change in Total Cholesterol From Baseline at Week 12
Description	The study was terminated; no outcome measure data analyses were conducted.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

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
Arm/Group Description	simvastatin 20 mg daily at nights for 12 weeks	Placebo daily at nights for 12 weeks
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
Description	The study was terminated; no outcome measure data analyses were conducted.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

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
Arm/Group Description	simvastatin 20 mg daily at nights for 12 weeks	Placebo daily at nights for 12 weeks
Measure Participants	0	0

4. Secondary Outcome

Title	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
Description	The study was terminated; no outcome measure data analyses were conducted.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

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
Arm/Group Description	simvastatin 20 mg daily at nights for 12 weeks	Placebo daily at nights for 12 weeks
Measure Participants	0	0

Adverse Events

Arm/Group Title	Simvastatin		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Simvastatin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Simvastatin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/0 (NaN)

Limitations/Caveats

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.

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.