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Please see Detailed Description for termination reason.
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The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.
Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alprazolam group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alprazolam XR | Drug | Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall | 24 weeks | |
| Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam | 6 week taper | |
| The incidence of treatment-emergent adverse event during treatment with alprazolam XR | 24 weeks with taper |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive estimates of the persistence of safety events and adverse events at study endpoint | 24 weeks with taper | |
| Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Alaska | 72223 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
|
| Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score | 24 weeks |
| Endpoint change from baseline to Week 24 in CGI-Severity score | 24 weeks |
| Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score | 24 weeks |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Pfizer Investigational Site | Scottsdale | Arizona | 85251 | United States |
| Pfizer Investigational Site | Burbank | California | 91506 | United States |
| Pfizer Investigational Site | El Centro | California | 92243 | United States |
| Pfizer Investigational Site | La Mesa | California | 91942 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90010 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | San Diego | California | 92111 | United States |
| Pfizer Investigational Site | San Marcos | California | 92078 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32610 | United States |
| Pfizer Investigational Site | Hialeah | Florida | 33013 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | North Miami | Florida | 33161 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33710 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30030 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83702 | United States |
| Pfizer Investigational Site | Schaumburg | Illinois | 60194 | United States |
| Pfizer Investigational Site | Terre Haute | Indiana | 47802 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66214 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40509 | United States |
| Pfizer Investigational Site | Owensboro | Kentucky | 42301 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70114 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21208 | United States |
| Pfizer Investigational Site | Clinton Township | Michigan | 48038 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55101 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Clementon | New Jersey | 08021 | United States |
| Pfizer Investigational Site | Kenilworth | New Jersey | 07033 | United States |
| Pfizer Investigational Site | Morristown | New Jersey | 07962 | United States |
| Pfizer Investigational Site | Bismarck | North Dakota | 59501 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106-5080 | United States |
| Pfizer Investigational Site | Lyndhurst | Ohio | 44124 | United States |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | United States |
| Pfizer Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033-0850 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19063 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Selmer | Tennessee | 38375-1645 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84117 | United States |
| Pfizer Investigational Site | Midlothian | Virginia | 23112 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Middleton | Wisconsin | 53562 | United States |
| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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