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NCT02019264 · ClinicalTrials.gov registry record · Phase 4

A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

A Phase 4 study, sponsored by Eisai.

Completed
Registry status
Phase 4
Development phase
14,673
Enrollment target

NCT02019264: Completed Phase 4 study, sponsored by Eisai.

NCT02019264 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 14,673 participants, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2738% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02019264, a Phase 4 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 4
Development phase
14,673 participants
Enrollment target

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.

Primary Outcome

The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.

Interventions

  • DRUG Placebo
  • DRUG Lorcaserin hydrochloride

Trial Details

FieldValue
Enrollment Target 14,673 participants
Start Date 2014-01-24
Est. Completion 2018-05-14
Phase Phase 4
Eisai

287 total trials

What the finished NCT02019264 record still lists

NCT02019264 is an interventional study that assigns participants to a tested intervention. Its 14,673 participants enrollment target places it among the larger protocols in the corpus, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (2738% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02019264 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02019264 about?

NCT02019264 is a clinical study titled "A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors". This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.

What is the current status of trial NCT02019264?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 14,673 participants. The study started on 2014-01-24. Estimated completion is 2018-05-14.

What interventions are being tested in trial NCT02019264?

The interventions under investigation include: Placebo (DRUG), Lorcaserin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT02019264?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02019264's enrollment target sits among peer trials

14,673 7th of 2000 higher than 1,994 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02019264, the US trial registry maintained by the National Library of Medicine. NCT02019264 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.