A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
NCT ID: NCT02044874
Last Updated: 2019-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
603 participants
INTERVENTIONAL
2014-03-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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APD356 10 mg b.i.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
APD356-lorcaserin hydrochloride
APD356 10 mg q.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
APD356-lorcaserin hydrochloride
Placebo 10 mg b.i.d
Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Placebo
Interventions
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APD356-lorcaserin hydrochloride
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
3. Able to give signed informed consent
4. Eligible female patients will be:
1. non-pregnant
2. non-lactating
3. agree to use an acceptable method of effective contraception during the study
5. Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
6. Body weight of ≥50 kg (110 pounds), inclusive
7. Considered to be in stable health in the opinion of the investigator
Exclusion Criteria
1. Prior or current use of lorcaserin HCl
2. Prior participation in any study of a nicotine vaccination
3. Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
4. Use of tobacco products other than cigarettes
5. Prior use of fenfluramine or dexfenfluramine
6. Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
7. Previous participation in any clinical study within 6 weeks prior to the screening visit
8. History of severe allergies, severe drug or excipient allergy or hypersensitivity
9. History of significant cardiovascular condition
10. History of other significant medical conditions
11. Significant risk of suicide
12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
14. Recent history of alcohol or drug/solvent abuse
15. Concurrent participation in the study by more than one member of the same household
16. Not suitable to participate in the study in the opinion of the investigator
18 Years
65 Years
ALL
No
Sponsors
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Arena Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Anderson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Desert Valley Research; Rancho Mirage, California
Locations
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Pharmacology Research Institute
Encino, California, United States
Synergy Escondido
Escondido, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Avail Clinical Research
DeLand, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Meridien Research
Lakeland, Florida, United States
Compass Research East
Leesburg, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Compass Research
Orlando, Florida, United States
Compass Research East
Oviedo, Florida, United States
Meridien Research
Tampa, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Duke University
Durham, North Carolina, United States
PMG Research Inc.
Raleigh, North Carolina, United States
PMG Research Inc.
Wilmington, North Carolina, United States
PMG Research Inc.
Winston-Salem, North Carolina, United States
Neurobehavioral Clinical Research
Canton, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Clinical Trial Center
Jenkintown, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Countries
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References
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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.
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.
Other Identifiers
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APD356-035
Identifier Type: -
Identifier Source: org_study_id
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