A Phase 4 interventional study of Atorvastatin and Placebo in Drug Intolerance, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-03.
Sponsored by University of Dundee · Phase 4, Interventional, and Basic science
Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.
The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.
University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants will receive atorvastatin (80 mg) orally once daily for 28 days.
Drug: Atorvastatin
The participants will receive matched placebo orally once daily for 28 days.
Drug: Placebo
Atorvastatin 80 mg once daily for 28 days.
Placebo once daily for 28 days.
The primary outcome will be the change in CK levels at the end of the treatment from baseline in both treatment periods.
Time frame: Measured at baseline (day 0) and day 29 of both treatment periods.
Plan to share: Yes — As per GoSHARE tissue bank protocol, the data derived from the existing samples will be returned to the tissue bank for research use.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Dundee