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The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AZD7325 5mg twice daily |
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| B | Experimental | AZD7325 15mg twice daily |
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| C | Active Comparator | Lorazepam 2mg twice daily |
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| D | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7325 | Drug | 4 tablets and 1 capsule taken twice a day for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization | Baseline to week 4 |
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Smith, MD, PhD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mesa | Arizona | United States | |||
| Research Site |
Screening for eligibility and wash-out of restriced medications
International multi-center study, 43 sites recruited between Dec 2008 and May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD7325 5 mg | AZD7325 5 mg twice daily (BID) |
| FG001 | AZD7325 15 mg | AZD7325 15 mg twice daily (BID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AZD7325 |
| Drug |
4 tablets and 1 capsule taken twice a day for 28 days |
|
| Lorazepam | Drug | 4 tablets and 1 capsule taken twice a day for 28 days |
|
| Placebo | Drug | 4 tablets and 1 capsule taken twice a day for 28 days |
|
The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder. Change: score at week 4 minus score at randomization |
| Baseline to week 4 |
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder. | Baseline to week 4 |
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score | Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 4 minus percentage at randomization | Baseline to week 4 |
| Little Rock |
| Arkansas |
| United States |
| Research Site | Carson | California | United States |
| Research Site | Escondido | California | United States |
| Research Site | Glendale | California | United States |
| Research Site | Irvine | California | United States |
| Research Site | Redlands | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sherman Oaks | California | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Gainsville | Florida | United States |
| Research Site | Hallandale | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | St. Petersburg | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Oak Brook | Illinois | United States |
| Research Site | Schaumburg | Illinois | United States |
| Research Site | Lafayette | Indiana | United States |
| Research Site | Terre Haute | Indiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Westminster | Maryland | United States |
| Research Site | Braintree | Massachusetts | United States |
| Research Site | Piscataway | New Jersey | United States |
| Research Site | Cedarhurst | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Willoughby | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Allentown | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Bartlett | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Wichita Falls | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Seattle | Washington | United States |
| FG002 |
| Lorazepam |
Lorazepam 2 mg twice daily (BID) |
| FG003 | Placebo | Placebo |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD7325 5 mg | AZD7325 5 mg twice daily (BID) |
| BG001 | AZD7325 15 mg | AZD7325 15 mg twice daily (BID) |
| BG002 | Lorazepam | Lorazepam 2 mg twice daily (BID) |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization | Posted | Least Squares Mean | Standard Error | Units on scale | Baseline to week 4 |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization | Posted | Least Squares Mean | Standard Error | Units on scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder. Change: score at week 4 minus score at randomization | Posted | Least Squares Mean | Standard Error | Units on scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder. | Posted | Least Squares Mean | Standard Error | Units on scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score | Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 4 minus percentage at randomization | Posted | Least Squares Mean | Standard Error | percentage | Baseline to week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD7325 5 mg | AZD7325 5 mg twice daily (BID) | 0 | 93 | 63 | 93 | ||
| EG001 | AZD7325 15 mg | AZD7325 15 mg twice daily (BID) | 0 | 92 | 59 | 92 | ||
| EG002 | Lorazepam | Lorazepam 2 mg twice daily (BID) | 0 | 92 | 65 | 92 | ||
| EG003 | Placebo | Placebo | 0 | 92 | 51 | 92 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Feeling Abnormal | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Feeling Drunk | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Euphoric Mood | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mood Altered | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C576237 | 4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 40-65 years |
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| Male |
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| Participants |
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