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Please see Detailed Description for the termination reason.
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The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.
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 |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| Alprazolam XR group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam | Week 24 (taper baseline), Weeks 25-29, and end of taper visit | |
| The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR | Weeks 6, 8, 12, 16, 20, and 24 | |
| Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Endpoint change from baseline in Hamilton Anxiety Rating scale | Weeks 12 and 24 | |
| Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores | Weeks 12 an 24 |
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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 | Eugene | Oregon | 97401 | 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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| alprazolam XR | Drug | Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced. |
|
|
| Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale | Weeks 12 and 24 |
| Endpoint change compared with baseline in CGI-Severity score | Weeks 12 and 24 |
| Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score | Weeks 12 and 24 |
| Descriptive estimates of the persistence of safety events and adverse events | Week 24 |
| San Antonio |
| Texas |
| 78229 |
| 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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