Attention Deficit Hyperactivity DisorderPhase 3NCT00723190

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study testing CLONICEL (Clonidine HCl sustained release) in people with Attention Deficit Hyperactivity Disorder, run by Shionogi at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: CLONICEL (Clonidine HCl sustained release)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 303 participants
Where: 27 sitesUnited States
Study dates: Jan 2008to Jun 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
Age between 6 and 17 years, inclusive
Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
General good health as judged by the Principal Investigator
Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
Subject as well as parent/guardian able to sign informed assent or consent form

Who cannot join

If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
Presence of alcohol or drug abuse.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Study site
Baltimore, Maryland, 21208
Study site
Bardstown, Kentucky, 40004
Study site
Bradenton, Florida, 34208
Study site
Chapel Hill, North Carolina, 27514
Study site
Charlotte, North Carolina, 28209
Study site
Cleveland, Ohio, 44106
Study site
Clinton, Utah, 84015
Study site
Durham, North Carolina, 27705
Study site
El Centro, California, 92243
Study site
Gainesville, Florida, 32607
Study site
Houston, Texas, 77007
Study site
Irvine, California, 92612
Study site
Jacksonville, Florida, 32216
Study site
Kirkland, Washington, 98033
Study site
Lake Jackson, Texas, 77566
Study site
Lauderhill, Florida, 33319
Study site
Little Rock, Arkansas, 72205
Study site
Miami, Florida, 33161
Study site
Oklahoma City, Oklahoma, 73103
Study site
Oklahoma City, Oklahoma, 73116
Study site
Orlando, Florida, 32806
Study site
Rochester Hills, Michigan, 48307
Study site
San Diego, California, 92103
Study site
St Louis, Missouri, 63005
Study site
Voorhees Township, New Jersey, 08043
Study site
Wharton, Texas, 77488
Study site
Willingboro, New Jersey, 08046

Other trials in United States

About this study

Official title: An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions: Attention Deficit Hyperactivity Disorder
Being tested: CLONICEL (Clonidine HCl sustained release)
Keywords: CLONICEL, Attention Deficit Hyperactivity Disorder, clonidine HCl sustained release
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLONICEL (Clonidine HCl sustained release)Drug
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

Study groups in NCT00723190
Study group	Role	What they receive
Arm A	Experimental	CLONICEL (Clonidine HCl sustained release) Receives: Drug: CLONICEL (Clonidine HCl sustained release)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 1 year
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and at Week 4
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Measured: At baseline and at Week 4

Secondary outcomes (3)

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
Measured: 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
Measured: 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
Measured: At baseline, months 1, 2, 3, 4, 6, 9, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2010

First posted28 Jul 2008 (estimated)
Study startJan 2008
Primary completionMar 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723190
Sponsor's protocol ID: CLON-303
Status last verified: Apr 2018
First submitted: 24 Jul 2008
Last updated: 18 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT00723190
Acronym / sponsor ID: CLON-303
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: CLONICEL, Attention Deficit Hyperactivity Disorder, clonidine HCl sustained release
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Mar 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 28 Jul 2008 (estimated)
Results: Posted 27 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm A	Experimental	Drug: CLONICEL (Clonidine HCl sustained release)CLONICEL (Clonidine HCl sustained release)

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
Age between 6 and 17 years, inclusive
Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
General good health as judged by the Principal Investigator
Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2

Key exclusion criteria (6 listed)

If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CLONICEL (Clonidine HCl sustained release)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	Drug	Arm A

Primary outcome

Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Time frame: 1 year
Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Time frame: 1 year
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
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
Time frame: At baseline and 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
Change From Baseline in Systolic Blood Pressure at Week 4
Time frame: At baseline and 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
Change From Baseline in Body Temperature at Week 4
Time frame: At baseline and 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
Change From Baseline in Heart Rate at Week 4
Time frame: At baseline and 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
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Time frame: At baseline and at Week 4

3 secondary outcomes

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
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
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
Time frame: At baseline, months 1, 2, 3, 4, 6, 9, and 12

Results and safety

Results posted to the registry on 27 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KAPVAY (CLONICEL)	303	161

Primary outcome: Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])

Time frame: 1 year. Number. Unit: Participants

Measure	KAPVAY (CLONICEL) n = 301
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

Population analysed: 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

Primary outcome: Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])

Time frame: 1 year. Number. Unit: Events

Measure	KAPVAY (CLONICEL) n = 301
Total number of TEAEs	954
Total number of related TEAEs	438
Total number of SAEs	2

Primary outcome: 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. Mean (Standard Deviation). Unit: milliseconds

Measure	KAPVAY (CLONICEL) n = 280
QT	17.9 (25.69)
QTcF	1.4 (16.42)
QTcB	-8.0 (22.15)

Population analysed: 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

Primary outcome: 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. Mean (Standard Deviation). Unit: Kilograms

Measure	KAPVAY (CLONICEL) n = 301
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)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KAPVAY (CLONICEL)	2 of 301 (0.7%)	246 of 301 (81.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Attention Deficit Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Not yet recruitingPhase 2
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Conduct Disorder
RecruitingObservational study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CLONICEL (Clonidine HCl sustained release) in people with Attention Deficit Hyperactivity Disorder, run by Shionogi at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.