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Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00428792
Recruitment Status : Completed
First Posted : January 30, 2007
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Methylphenidate 20 mg long-acting capsules
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB)
Hide Arm/Group Description Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Period Title: Overall Study
Started 80 70
Completed 79 [1] 66 [1]
Not Completed 1 4
Reason Not Completed
Lack of Efficacy             1             3
Lost to Follow-up             0             1
[1]
Information is not available during which cross-over period patients discontinued.
Arm/Group Title Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB) Total
Hide Arm/Group Description Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. Total of all reporting groups
Overall Number of Baseline Participants 80 70 150
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 70 participants 150 participants
9.6  (1.6) 9.7  (1.5) 9.7  (1.6)
[1]
Measure Description: Safety Population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 70 participants 150 participants
Female
25
  31.3%
13
  18.6%
38
  25.3%
Male
55
  68.8%
57
  81.4%
112
  74.7%
[1]
Measure Description: Safety Population
1.Primary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population
Hide Description The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Friday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.97  (0.63) 1.01  (0.63)
2.Primary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population
Hide Description The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Friday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 131 131
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.93  (0.62) 1.0  (0.63)
3.Secondary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating
Hide Description Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Friday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.19  (0.68) 1.23  (0.69)
4.Secondary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating
Hide Description Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Friday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.72  (0.70) 0.75  (0.69)
5.Secondary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating
Hide Description Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Friday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.93  (0.92) 0.99  (0.90)
6.Secondary Outcome
Title Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating
Hide Description The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
Time Frame Saturday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.15  (0.60) 1.11  (0.55)
7.Secondary Outcome
Title 10-Minute Math Test – Problems Attempted
Hide Description The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.
Time Frame Saturday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Problems attempted
116.3  (56.14) 118.1  (57.74)
8.Secondary Outcome
Title 10-Minute Math Test – Problems Solved
Hide Description The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.
Time Frame Saturday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Problems solved
106.7  (58.34) 108.6  (60.67)
9.Secondary Outcome
Title Clinical Global Impression Severity (CGI-S) Scale Score – Physician Rating of Severity
Hide Description The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.
Time Frame Saturday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 142 143
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.75  (1.45) 2.74  (1.48)
10.Secondary Outcome
Title Clinical Global Impression (CGI-I) Scale Score – Physician Rating of Improvement (Change in State)
Hide Description The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: “Compared to the patient’s condition prior to medication, this patient’s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.” The investigator compares the patient’s overall clinical condition to the 1 week period just prior to the initiation of medication.
Time Frame Saturday of each of the 2 treatment weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Very Light Breakfast (VLB) Treatment Group Standard Breakfast (SB) Treatment Group
Hide Arm/Group Description:
Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Overall Number of Participants Analyzed 142 142
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.49  (1.08) 3.56  (1.18)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All randomized patients who took at least 1 dose of study drug in 1 of the 2 treatment periods.
 
Arm/Group Title Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB)
Hide Arm/Group Description Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
All-Cause Mortality
Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   0/149 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Very Light Breakfast (VLB) Then Standard Breakfast (SB) Standard Breakfast (SB) Then Very Light Breakfast (VLB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   0/149 (0.00%) 
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00428792     History of Changes
Other Study ID Numbers: CRIT124DDE04
First Submitted: January 29, 2007
First Posted: January 30, 2007
Results First Submitted: January 6, 2011
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011