A randomised placebo-controlled trial of fixed-dose combination medication in people at raised risk of cardiovascular disease

Phase 2

Completed

• Conditions: cardiovascular; hypertension; 10011082; 10003216

• Registration Number: NL-OMON33869
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

Adults (> 18 years) with a cardiovascular disease (CVD) risk over 5 years of at least 7.5%, determined by the Framingham risk function (Anderson, 1991) using data on age, gender, blood pressure, total cholesterol, HDL cholesterol, diabetes status and cigarette smoking status.

Exclusion Criteria

Clear indication for antiplatelet, blood pressure lowering or cholesterol lowering medications. This includes: current treatment with blood pressure or cholesterol lowering medicines, diabetes mellitus, existing CVD, or individuals with LDL cholesterol, systolic blood pressure or estimated CVD risk values above those recommended for treatment by local guidelines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the efficacy (systolic blood pressure, LDL cholesterol) and<br /><br>tolerability (the proportion who withdraw from trial treatment). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Treatment adherence (measured by pill count), diastolic blood pressure, total<br /><br>cholesterol, HDL cholesterol, total cholesterol:HDL cholesterol ratio, non HDL<br /><br>cholesterol, triglycerides, frequency of switching to open-label treatment,<br /><br>estimated CVD risk, serious adverse events and all adverse events. </p><br>