Cardiovascular Morbidity and Mortality in Subjects with CVD
Research type
Research Study
Full title
A Qsymia(TM) CardiovascuLAr morbIdity and Mortality (AQCLAIM) Study in Subjects with Documented Cardiovascular Disease
IRAS ID
134745
Contact name
Nick Finer
Contact email
Sponsor organisation
Vivus Inc.
Eudract number
2012-003946-34
Research summary
The investigational study drug VI-0521 is being developed by VIVUS Inc. It is a combination of 2 drugs, phentermine (approved in the US since 1959 for weight loss) and topiramate (approved in the US since 1996 for seizure and migraine prevention). VI-0521 was approved by the US Food and Drug Administration (FDA) in July 2012 under the trade name Qsymia for the treatment of weight management in overweight and obese adults. This study will test whether VI-0521 or placebo (contains no active drug substance) reduce the chances of developing health problems related to the functioning of the heart and vascular system (blood vessels), such as heart attacks or strokes.
The study drug has been tested in humans previously and is generally safe and well tolerated.
Approximately 16,000 participants from sites all over the world will be recruited into the study. Approximately 400 participants will be recruited in the UK. The duration of participation depends on when a participant is enrolled into the trial. The duration of the trial will be determined by the number of events that occur, so the average duration is expected to be 3 years however the exact duration of participation may be shorter or longer. If the participant is in the study for 3 years they will be required to visit the clinic approximately 13 times. Participants will be randomly selected (by chance) to receive either VI-0521 (7.5 mg phentermine/ 46 mg topiramate) or placebo (this study is double-blind, placebo controlled). At certain times during the study there is a chance that the dose may be changed as determined by the study doctor.
The study is made up of a screening period (up to 28 days), treatment period lasting up to 3 years and a final visit. Participants who stop taking study drug before the end of the study will still be followed up for long term safety information.
Study procedures include medical history, physical examination, weight, height, BMI, waist circumference, blood pressure and heart rate, urine tests, blood tests and ECG.REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/1239
Date of REC Opinion
30 Oct 2013
REC opinion
Further Information Favourable Opinion