At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 14,673 enrolled
Drug / intervention
Lorcaserin hydrochloride +1 moredrug
Likely dose
Lorcaserin hydrochloride 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group 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
In Brief
A Phase 4 clinical trial evaluating Lorcaserin hydrochloride and Placebo for Cardiovascular Disease and 4 related conditions. Completed, enrolled 14,673 participants across 499 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Chile, Mexico, New Zealand, Poland, The Bahamas, United States
CollaboratorsThe TIMI Study Group
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionMay 2018
TodayJul 2026
First PostedDec 24, 2013
Enrollment StartJan 24, 2014
Primary CompletionMay 14, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.5 years ago
Interventions
Lorcaserin hydrochloridedrug
APD356 10 mg twice daily
Placebodrug
Placebo twice daily