Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Schanberg, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00065806
First received: August 1, 2003
Last updated: July 15, 2013
Last verified: July 2013
Results First Received: February 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Lupus Erythematosus, Systemic
Interventions: Drug: Atorvastatin
Drug: Placebo atorvastatin

  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
No text entered.

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
1 Atorvastatin

Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.

Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.

2 Placebo

Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.

Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.


Participant Flow:   Overall Study
    1 Atorvastatin     2 Placebo  
STARTED     113     108  
COMPLETED     93     89  
NOT COMPLETED     20     19  



  Baseline Characteristics
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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
1 Atorvastatin

Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.

Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.

2 Placebo

Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.

Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.

Total Total of all reporting groups

Baseline Measures
    1 Atorvastatin     2 Placebo     Total  
Number of Participants  
[units: participants]
  113     108     221  
Age  
[units: participants]
     
<=18 years     87     87     174  
Between 18 and 65 years     26     21     47  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.7  ± 2.8     15.8  ± 2.5     15.7  ± 2.6  
Gender  
[units: participants]
     
Female     95     89     184  
Male     18     19     37  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean-Mean Common Carotid IMT (CIMT)   [ Time Frame: Change from baseline to 36 months ]

2.  Secondary:   Change in Mean-Max CIMT   [ Time Frame: Change from baseline to 36 months ]

3.  Secondary:   Change in Mean-Mean CIMT   [ Time Frame: Change from baseline to 36 months ]

4.  Secondary:   Change in Mean-Max Common CIMT   [ Time Frame: Change from baseline to 36 months ]

5.  Secondary:   Change in Mean-Max Internal CIMT   [ Time Frame: Change from baseline to 36 months ]

6.  Secondary:   Change in Mean-Mean Internal CIMT   [ Time Frame: Change from baseline to 36 months ]

7.  Secondary:   Change in Mean-Max Bifurcation CIMT   [ Time Frame: Change from baseline to 36 months ]

8.  Secondary:   Change in Mean-Mean Bifurcation CIMT   [ Time Frame: Change from baseline to 36 months ]

9.  Secondary:   Change in Mean-Max Far Wall CIMT   [ Time Frame: Change from baseline to 36 months ]

10.  Secondary:   Change in Mean-Mean Far Wall CIMT   [ Time Frame: Change from baseline to 36 months ]

11.  Secondary:   Change in Mean-Max Near Wall CIMT   [ Time Frame: Change from baseline to 36 months ]

12.  Secondary:   Change in Mean-Mean Near Wall CIMT   [ Time Frame: Change from baseline to 36 months ]

13.  Secondary:   Change in Natural Log of mg/L for hsCRP   [ Time Frame: Change from baseline to 36 months ]

14.  Secondary:   Change in Total Cholesterol   [ Time Frame: Change from baseline to 36 months ]

15.  Secondary:   Change in HDL Cholesterol   [ Time Frame: Change from baseline to 36 months ]

16.  Secondary:   Change in LDL Cholesterol   [ Time Frame: Change from baseline to 36 months ]

17.  Secondary:   Change in Triglycerides   [ Time Frame: Change from baseline to 36 months ]

18.  Secondary:   Change in Lipoprotein A   [ Time Frame: Change from baseline to 36 months ]

19.  Secondary:   Change in Homocysteine   [ Time Frame: Change from baseline to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  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:
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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Laura Schanberg, MD
Organization: Duke University Medical Center
phone: 919-684-6575
e-mail: laura.schanberg@duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Laura Schanberg, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00065806     History of Changes
Other Study ID Numbers: Pro00006680, NIAMS-090, N01 AR022265
Study First Received: August 1, 2003
Results First Received: February 11, 2013
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board