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To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8529 low dose | Active Comparator | 1.5 mg |
|
| AZD8529 high dose | Active Comparator | 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8529 | Drug | comparison of different dosages of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13) | Weeks 10 - 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shwe Gyaw, MD | National Institute on Drug Abuse (NIDA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacology Research Institute | Encino | California | 91316 | United States | ||
| Pacific Treatment and Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD8529 Low Dose | Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks |
| FG001 | AZD8529 High Dose | Participants received AZD8529 40 mg capsule orally once daily for 13 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD8529 Low Dose | Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks |
| BG001 | AZD8529 High Dose | Participants received AZD8529 40 mg capsule orally once daily for 13 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Abstinence | The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13) | Subjects who received at least one dose of AZD8529 were included in this population. | Posted | Count of Participants | Participants | Weeks 10 - 13 |
|
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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 | AZD8529 Low Dose | Participants received AZD8529 1.5 mg capsule orally once daily for 13 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy with sponteneous abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liza Zeinert | National Institute on Drug Abuse | 301-443-1138 | liza.zeinert@nih.gov |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000608263 | AZD8529 |
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| La Jolla |
| California |
| 92037 |
| United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| University of Maryland - College Park | College Park | Maryland | 20742 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45229 | United States |
| Centers for the Studies of Addiction | Philadelphia | Pennsylvania | 19104 | United States |
| Virginia Commonwelath University | Richmond | Virginia | 23219 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 74 |
| 104 |
| EG001 | AZD8529 High Dose | Participants received AZD8529 40 mg capsule orally once daily for 13 weeks | 0 | 110 | 3 | 110 | 85 | 110 |
| Hidrandenitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Small cell lunch cancer | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Pollakiuria | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Antrioventricular block first degree | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Colour blindness | Congenital, familial and genetic disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D015438 |
| Health Behavior |