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The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLONICEL (clonidine HCl sustained release) | Drug | Flexible Dose (0.1 - 0.4 mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ADHDRS-IV Total Score | Week 5 | |
| Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs | Throughout Treatment and Follow-up Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moise Khayrallah, PhD | Addrenex Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
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| Placebo |
| Drug |
Matching placebo tablets |
|
| El Centro |
| California |
| 92243 |
| United States |
| Irvine | California | 92612 | United States |
| San Diego | California | 92103 | United States |
| Bradenton | Florida | 34208 | United States |
| Lauderhill | Florida | 33319 | United States |
| Miami | Florida | 33161 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Baltimore | Maryland | 21208 | United States |
| St Louis | Missouri | 63005 | United States |
| Clementon | New Jersey | 08021 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Durham | North Carolina | 27705 | United States |
| Cleveland | Ohio | 44106 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma City | Oklahoma | 73116 | United States |
| Houston | Texas | 77007 | United States |
| Houston | Texas | 77074 | United States |
| Lake Jackson | Texas | 77566 | United States |
| Wharton | Texas | 77488 | United States |
| Clinton | Utah | 84015 | United States |
| Kirkland | Washington | 98033 | United States |
| Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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