Hypercholesterolaemia and Hypertension MedDRA version: N/A Level: LLT Classification code 10020603 Term: Hypercholesterolaemia MedDRA version: N/A Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: Polypill
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
CAS Number: 79902-63-9
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be men and women aged 50 years and older, without a history of heart attack or stroke or selection based on other risk factors, for whom there is no medical contra-indication to taking the Polypill. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ineligibility criteria include: (i) a clinical history of cardiovascular disease (ii) any illness judged to contra-indicate participation in the trial (iii) 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 |
|---|---|
| Main Objective: The objective is to determine the reduction in serum cholesterol and blood pressure using the Polypill. ; Secondary Objective: To assess: (i) the prevalence of adverse effects of treatment (ii) adherence to treatment ;Primary end point(s): The primary outcome measure is the placebo – adjusted reduction in total and LDL cholesterol and systolic and diastolic blood pressure. | — |
Countries
United Kingdom
Outcome results
None listed