Cardiovascular Disease Circulatory System Cardiovascular Disease
Conditions
Interventions
Polypill (containing simvastatin, losartan, amlodipine and hydrochlorothiazide) - Each treatment arm lasts 12 weeks and consists of polypill or placebo in random order, followed by a 2 year open label
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 50 and over, without selection on the basis of other risk factors, for whom there is no medical contra-indication to taking the Polypill
Exclusion criteria
Exclusion criteria: 1. Clinical history of cardiovascular disease 2. Any illness judged to contra-indicate participation in the trial 3. Taking other specified drugs: lithium, cyclosporine or other calcineurin inhibitors, erythromycin or other macrolides, azole antifungals, ritonavir or other protease inhibitors, amiodarone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serum cholesterol 2. Systolic blood pressure 3. Diastolic blood pressure Outcomes assessed at the end of each 12 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effects 2. Adherence | — |
Countries
United Kingdom
Outcome results
None listed