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)
4
2
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
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:

    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
    Pre-assignment Detail
    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

    Time Frame
    Adverse Event Reporting Description
    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.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    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