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Trial record 80 of 326 for:    clonidine

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents 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: NCT00723190
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : February 27, 2012
Last Update Posted : April 18, 2018
Sponsor:
Information provided by:
Shionogi Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: CLONICEL (Clonidine HCl sustained release)
Enrollment 303
Recruitment Details This was a multicenter study conducted at 27 study centers in the United States. First subject visit was on January 09, 2008 and last subject completed the study on March 08, 2010
Pre-assignment Details Candidates enrolled in this study (CLON-303) were subjects who completed studies using KAPVAY (CLONICEL) as add-on therapy with stimulants (CLON-302) and as monotherapy (CLON-301). There was no screening period for this study. The safety follow-up visit from these two prior studies (CLON-301 and CLON-302) was the baseline visit for current study
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Period Title: Overall Study
Started 303 [1]
SAFETY POPULATION 301
Completed 161 [2]
Not Completed 142
Reason Not Completed
Withdrawal by Subject             45
Lost to Follow-up             37
Adverse Event             18
Lack of Efficacy             16
Protocol Violation             15
Other-Premature Discontinuation             9
Other-Not included in safety population             2
[1]
Study CLON-301 (168 participants) and Study CLON-302 (135 participants)
[2]
53 participants completed 6-month protocol and 108 participants completed 12-month protocol
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Baseline Participants 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants
10.1  (2.75)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 301 participants
10.0
(6.0 to 17.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants
6-12 Years 239
> 12-17 Years 62
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants
Female
80
  26.6%
Male
221
  73.4%
[1]
Measure Description: Baseline characteristics are presented for the subjects in the safety population (total 301 participants)
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants
White 186
Black/African American 69
Hispanic or Latino 25
Other 21
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 301 participants
42.3  (18.94)
[1]
Measure Description: Data collected from 291 participants
Weight   [1] 
Median (Full Range)
Unit of measure:  Kilograms
Number Analyzed 301 participants
38.1
(19.6 to 131.0)
[1]
Measure Description: Data collected from 291 participants
1.Primary Outcome
Title Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 301
Measure Type: Number
Unit of Measure: Participants
Total Safety Population 301
Subjects with ≥1 TEAEs 246
Subjects with ≥1 related TEAEs 178
Subjects with ≥1 SAEs 2
Subjects with ≥1 TEAEs leading to discontinuation 17
2.Primary Outcome
Title Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 301
Measure Type: Number
Unit of Measure: Events
Total number of TEAEs 954
Total number of related TEAEs 438
Total number of SAEs 2
3.Primary Outcome
Title Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4
Hide Description [Not Specified]
Time Frame At baseline and at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 280
Mean (Standard Deviation)
Unit of Measure: milliseconds
QT 17.9  (25.69)
QTcF 1.4  (16.42)
QTcB -8.0  (22.15)
4.Primary Outcome
Title Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
Hide Description [Not Specified]
Time Frame At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 301
Mean (Standard Deviation)
Unit of Measure: Kilograms
week 1 (n = 283) 0.3  (2.25)
week 2 (n = 283) 0.4  (2.28)
week 3 (n = 278) 0.6  (2.39)
week 4 (n = 269) 0.7  (2.42)
month 2 (n = 246) 0.9  (2.61)
month 3 (n = 232) 1.2  (2.97)
month 4 (n = 212) 1.4  (3.25)
month 5 (n = 47) 1.7  (5.63)
month 6 (n = 204) 2.1  (3.84)
month 9 (n = 123) 3.6  (3.72)
month 12 (n = 123) 4.5  (4.83)
5.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.2  (9.13)
6.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: mmHg
-5.0  (10.71)
7.Primary Outcome
Title Change From Baseline in Body Temperature at Week 4
Hide Description Temperature 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 278
Mean (Standard Deviation)
Unit of Measure: Fahrenheit
-0.08  (0.791)
8.Primary Outcome
Title Change From Baseline in Heart Rate at Week 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: beats per minute
-7.0  (13.59)
9.Primary Outcome
Title Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Hide Description [Not Specified]
Time Frame At baseline and at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 280
Mean (Standard Deviation)
Unit of Measure: beats per minute
-10.6  (14.32)
10.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 290
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1-month (n = 229) -13.7  (11.52)
2-month (n = 221) -14.4  (11.73)
3-month (n = 203) -14.8  (12.55)
4-month (n = 142) -16.3  (12.59)
6-month (n = 184) -14.6  (12.04)
9-month (n = 119) -18.1  (12.66)
12-month (n = 98) -14.6  (14.05)
11.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 301
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1-month (n = 229) -1.2  (1.17)
2-month (n = 220) -1.3  (1.12)
3-month (n = 202) -1.3  (1.29)
4-month (n = 143) -1.5  (1.19)
6-month (n = 185) -1.4  (1.15)
9-month (n = 119) -1.7  (1.35)
12-month (n = 97) -1.4  (1.46)
12.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description:
One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
Overall Number of Participants Analyzed 301
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1-month (n = 229) 2.5  (1.05)
2-month (n = 220) 2.5  (1.11)
3-month (n = 202) 2.5  (1.10)
4-month (n = 143) 2.3  (1.04)
6-month (n = 185) 2.4  (1.11)
9-month (n = 119) 2.1  (1.11)
12-month (n = 97) 2.4  (1.39)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KAPVAY (CLONICEL)
Hide Arm/Group Description One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
All-Cause Mortality
KAPVAY (CLONICEL)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
KAPVAY (CLONICEL)
Affected / at Risk (%)
Total   2/301 (0.66%) 
Infections and infestations   
Cellulitis  1/301 (0.33%) 
Psychiatric disorders   
Suicidal Behavior  1/301 (0.33%) 
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
KAPVAY (CLONICEL)
Affected / at Risk (%)
Total   246/301 (81.73%) 
Cardiac disorders   
Dizziness  9/301 (2.99%) 
Ear and labyrinth disorders   
Otitis Media Acute  6/301 (1.99%) 
Gastrointestinal disorders   
Abdominal Pain Upper  37/301 (12.29%) 
Vomiting  17/301 (5.65%) 
Nausea  12/301 (3.99%) 
Diarrhoea  9/301 (2.99%) 
Constipation  8/301 (2.66%) 
General disorders   
Fatigue  37/301 (12.29%) 
Irritability  28/301 (9.30%) 
Immune system disorders   
Rhinitis Seasonal  7/301 (2.33%) 
Dermatitis Contact  6/301 (1.99%) 
Infections and infestations   
Upper Respiratory Tract Infection  39/301 (12.96%) 
Gastroenteritis Viral  20/301 (6.64%) 
Nasopharyngitis  10/301 (3.32%) 
Injury, poisoning and procedural complications   
Hand Fracture  6/301 (1.99%) 
Investigations   
Body Temperature Increased  22/301 (7.31%) 
Weight Increased  11/301 (3.65%) 
Metabolism and nutrition disorders   
Decreased Appetite  25/301 (8.31%) 
Nervous system disorders   
Headache  49/301 (16.28%) 
Insomnia  28/301 (9.30%) 
Psychiatric disorders   
Somnolence  96/301 (31.89%) 
Affect Lability  12/301 (3.99%) 
Emotional Disorder  6/301 (1.99%) 
Respiratory, thoracic and mediastinal disorders   
Cough  25/301 (8.31%) 
Nasal Congestion  18/301 (5.98%) 
Pharyngolaryngeal Pain  16/301 (5.32%) 
Influenza  8/301 (2.66%) 
Respiratory Tract Congestion  6/301 (1.99%) 
Skin and subcutaneous tissue disorders   
Rash  6/301 (1.99%) 
1
Term from vocabulary, MedDRA 10.0
Efficacy results need to be reviewed in the context that the study is an open-label/non-placebo controlled study. No formal statistical testing of efficacy results has been done. No adjustments have been made to account for drop-outs or missing data.
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 sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi USA
Phone: 800-849-9707 ext 1454
EMail: shionogiclintrialsadmin@shionogi.com
Layout table for additonal information
Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00723190     History of Changes
Other Study ID Numbers: CLON-303
First Submitted: July 24, 2008
First Posted: July 28, 2008
Results First Submitted: September 20, 2011
Results First Posted: February 27, 2012
Last Update Posted: April 18, 2018