SAMSON
Trial Details
- Trial statusRecruiting
- Study email contactf.wood@imperial.ac.uk
- Chief InvestigatorProfessor Darrel Francis
- Project managerFrances Wood
- SponsorImperial College
- Phase4
- View clinicaltrials.gov website
Self-Assessment Method for Statin side-effects Or Nocebo
Design and Objective
Design: Double-blind, crossover, randomised controlled trial. Objectives: Develop a method for determining within an individual participant to what extent experienced symptoms are associated with the statin and to evaluate in a cohort of participants who have stopped statins because of adverse symptoms, in what proportion of them, the symptoms are truly due to the statin.
Key inclusion criteria
INCLUSION CRITERIA FOR MAIN TRIAL: • Previously taken one or more statins • Withdrawn from statins because of perceived side effects • Developed side effects within 2 weeks of initiation • Clinical indication for statins for primary or secondary prevention of cardiovascular disease or dyslipidaemia