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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

NCT02019264 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14673

Last updated 2019-07-16

Study results available
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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.

Conditions

Interventions

DRUG

Lorcaserin hydrochloride

APD356 10 mg twice daily

DRUG

Placebo

Placebo twice daily

Sponsors & Collaborators

  • The TIMI Study Group

    collaborator OTHER

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-24
Primary Completion
2018-05-14
Completion
2018-05-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Mexico
  • New Zealand
  • Poland
  • The Bahamas

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019264 on ClinicalTrials.gov