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In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD356 10 mg b.i.d. | Experimental | APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks |
|
| APD356 10 mg q.d. | Experimental | APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks |
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| Placebo 10 mg b.i.d | Placebo Comparator | Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD356-lorcaserin hydrochloride | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm. | Week 9 - Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence During Weeks 3-12 | The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Week 3 to Week 12 |
| The 7 Day Point Prevalence or Weekly Abstinence at Week 8 |
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Inclusion Criteria:
Males or females aged 18-65 years, inclusive
≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
Able to give signed informed consent
Eligible female patients will be:
Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
Body weight of ≥50 kg (110 pounds), inclusive
Considered to be in stable health in the opinion of the investigator
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Donald Anderson, M.D. | Desert Valley Research; Rancho Mirage, California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacology Research Institute | Encino | California | 91316 | United States | ||
| Synergy Escondido |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611902 | Derived | Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. | |
| 27815511 | Derived | Shanahan WR, Rose JE, Glicklich A, Stubbe S, Sanchez-Kam M. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res. 2017 Aug 1;19(8):944-951. doi: 10.1093/ntr/ntw301. |
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| ID | Title | Description |
|---|---|---|
| FG000 | APD356 10 mg b.i.d. | APD356-lorcaserin hydrochloride |
| FG001 | APD356 10 mg q.d. | APD356-lorcaserin hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
|
The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm |
| Week 8 |
| The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Week 12 |
| Body Weight | Change in body weight from Week 1 (baseline) to Week 12 | Baseline to Week 12 |
| Escondido |
| California |
| 92025 |
| United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Desert Valley Research | Rancho Mirage | California | 92270 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Compass Research East | Leesburg | Florida | 34748 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Compass Research East | Oviedo | Florida | 32765 | United States |
| Meridien Research | Tampa | Florida | 33606 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Quality Clinical Research Inc. | Omaha | Nebraska | 68114 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| PMG Research Inc. | Raleigh | North Carolina | 27609 | United States |
| PMG Research Inc. | Wilmington | North Carolina | 28401 | United States |
| PMG Research Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Neurobehavioral Clinical Research | Canton | Ohio | 44718 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | United States |
| Lincoln Research | Lincoln | Rhode Island | 02865 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| FG002 |
| Placebo 10 mg b.i.d |
Placebo |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | APD356 10 mg b.i.d. | APD356-lorcaserin hydrochloride 10 mg twice daily |
| BG001 | APD356 10 mg q.d. | APD356-lorcaserin hydrochloride 10 mg once daily |
| BG002 | Placebo 10 mg b.i.d | Placebo 10 mg twice daily |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm. | Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement | Posted | Number | percentage of participants | Week 9 - Week 12 |
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| Secondary | Abstinence During Weeks 3-12 | The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement | Posted | Number | percentage of participants | Week 3 to Week 12 |
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| Secondary | The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement | Posted | Number | percentage of participants | Week 8 |
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| Secondary | The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement | Posted | Number | percentage of paticipants | Week 12 |
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| Secondary | Body Weight | Change in body weight from Week 1 (baseline) to Week 12 | Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement | Posted | Least Squares Mean | 95% Confidence Interval | Kg | Baseline to Week 12 |
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Adverse events were collected from screening through the follow-up visit at Week 14 for a total period of up to 17 weeks.
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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 | APD356 10 mg b.i.d. | APD356-lorcaserin hydrochloride 10 mg twice daily | 3 | 201 | 70 | 201 | ||
| EG001 | APD356 10 mg q.d. | APD356-lorcaserin hydrochloride 10 mg once daily | 4 | 202 | 65 | 202 | ||
| EG002 | Placebo | Placebo | 1 | 200 | 68 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| Blood carbon monoxide increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Demonstration of sustained abstinence requires a study of >12 weeks duration.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Document Operations | Arena Pharmaceuticals, Inc | 858-453-7200 | ct.gov@arenapharm.com |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Odds Ratio (OR) |
| 1.60 |
| 2-Sided |
| 95 |
| 0.73 |
| 3.51 |
| Superiority or Other |
| Regression, Logistic | 0.0477 | Odds Ratio (OR) | 1.89 | 2-Sided | 95 | 1.01 | 3.56 | Superiority or Other |
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