The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
303
0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4
Unnamed facility
Little Rock, Arkansas, United States
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population
Time frame: 1 year
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
Time frame: 1 year
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
Time frame: At baseline and at Week 4
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
Time frame: At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Change From Baseline in Diastolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time frame: At baseline and at Week 4
Change From Baseline in Systolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time frame: At baseline and at Week 4
Change From Baseline in Body Temperature at Week 4
Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
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Unnamed facility
El Centro, California, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Lauderhill, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
...and 17 more locations
Time frame: At baseline and at Week 4
Change From Baseline in Heart Rate at Week 4
Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Time frame: At baseline and at Week 4
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Time frame: At baseline and at Week 4
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12
The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-S scale: 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-I scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12