Trial · NCT02044874
A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
NCT02044874, Phase 2, Completed, Arena Pharmaceuticals; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation. Trials, record NCT02044874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02044874
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
- NCT number
- NCT02044874
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 603 participants, actual
- Lead sponsor
- Arena Pharmaceuticals
- Conditions
- Smoking Cessation
- Interventions
- APD356-lorcaserin hydrochloride, Placebo
- First posted
- 2014-01-24
- Last updated
- 2019-04-16
- Results first posted
- 2019-04-16
- Limitations and caveats
- Demonstration of sustained abstinence requires a study of \>12 weeks duration.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Week 9 - Week 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. |
| Secondary | Abstinence During Weeks 3-12 | Week 3 to Week 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 |
| Secondary | The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | 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 |
| Secondary | The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | 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 |
| Secondary | Body Weight | Baseline to Week 12 | Change in body weight from Week 1 (baseline) to Week 12 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Week 9 - 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 | percentage of participants | NUMBER |
| SECONDARY | Abstinence During Weeks 3-12 | Week 3 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 | percentage of participants | NUMBER |
| SECONDARY | The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | Week 8 | 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 | percentage of participants | NUMBER |
| SECONDARY | The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | 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 | percentage of paticipants | NUMBER |
| SECONDARY | Body Weight | 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 | Kg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | APD356 10 mg b.i.d. | 15.31 | percentage of participants | ||
| Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | APD356 10 mg q.d. | 8.72 | percentage of participants | ||
| Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Placebo | 5.64 | percentage of participants | ||
| Abstinence During Weeks 3-12 | APD356 10 mg b.i.d. | 5.61 | percentage of participants | ||
| Abstinence During Weeks 3-12 | APD356 10 mg q.d. | 3.59 | percentage of participants | ||
| Abstinence During Weeks 3-12 | Placebo | 2.05 | percentage of participants | ||
| The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | APD356 10 mg b.i.d. | 16.33 | percentage of participants | ||
| The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | APD356 10 mg q.d. | 9.74 | percentage of participants | ||
| The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | Placebo | 9.23 | percentage of participants | ||
| The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | APD356 10 mg b.i.d. | 20.41 | percentage of paticipants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APD356 10 mg b.i.d. | 201 | |
| Overall Study | STARTED | APD356 10 mg q.d. | 202 | |
| Overall Study | STARTED | Placebo 10 mg b.i.d | 200 | |
| Overall Study | COMPLETED | APD356 10 mg b.i.d. | 171 | |
| Overall Study | COMPLETED | APD356 10 mg q.d. | 147 | |
| Overall Study | COMPLETED | Placebo 10 mg b.i.d | 140 | |
| Overall Study | NOT COMPLETED | APD356 10 mg b.i.d. | 30 | |
| Overall Study | NOT COMPLETED | APD356 10 mg q.d. | 55 | |
| Overall Study | NOT COMPLETED | Placebo 10 mg b.i.d | 60 |
Source ClinicalTrials.gov
Adverse events87
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | APD356 10 mg b.i.d. | 16 | 201 | 16 |
| other | Nausea | Gastrointestinal disorders | APD356 10 mg q.d. | 9 | 202 | 9 |
| other | Nausea | Gastrointestinal disorders | Placebo | 10 | 200 | 10 |
| other | Constipation | Gastrointestinal disorders | APD356 10 mg b.i.d. | 12 | 201 | 12 |
| other | Constipation | Gastrointestinal disorders | APD356 10 mg q.d. | 13 | 202 | 13 |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 200 | 7 |
| other | Dry mouth | Gastrointestinal disorders | APD356 10 mg b.i.d. | 10 | 201 | 10 |
| other | Dry mouth | Gastrointestinal disorders | APD356 10 mg q.d. | 7 | 202 | 7 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 200 | 6 |
| other | Fatigue | General disorders | APD356 10 mg b.i.d. | 11 | 201 | 11 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APD356 10 mg b.i.d. | ||
| Total, all-cause mortality | APD356 10 mg q.d. | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | APD356 10 mg b.i.d. | 70 | 201 |
| Total, other adverse events | APD356 10 mg q.d. | 65 | 202 |
| Total, other adverse events | Placebo | 68 | 200 |
| Total, serious adverse events | APD356 10 mg b.i.d. | 3 | 201 |
| Total, serious adverse events | APD356 10 mg q.d. | 4 | 202 |
| Total, serious adverse events | Placebo | 1 | 200 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02044874
GET https://conductscience.org/api/trials/v1/NCT02044874/events?page=2