A randomised, double blind, parallel-group study of the oxidative stress lowering effect of simvastatin and atorvastatin.

A randomised, double blind, parallel-group study of the oxidative stress lowering effect of simvastatin and atorvastatin. - The oxidative stress lowering effects of statins

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30464

Enrollment

Registered

2007-04-03

Start date

2006-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arteriosclerosis Atherosclerosis

Interventions

All included patients are randomized to treatment with simvastatin 40 mg daily or atorvastatin 10 mg daily to achieve a comparable lipid reduction.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients in the age between 18 and 70 years, with diabetes mellitus type 2 and/or hypertension (RR > 140/90 mmHg) and/or obesity (BMI >25) and LDL > 2,5 mmol/l.

Exclusion criteria

Exclusion criteria: Stage 5 chronic kidney disease Use of an ACE inhibitor Statin use in three months prior to inclusion LDL cholesterol

Design outcomes

Primary

Measure	Time frame
Considering that there is no gold standard to measure effect on oxidative stress, established parameters of oxidative stress such as oxidized LDL, malondealdehyde and isoprostane will be measured in plasma and urine. All parameters of oxidative stress before and during treatment with one of both statins will be compared to determine whether atorvastatin causes a stronger and quicker reduction of oxidative stress than simvastatin.	—

Measure

Time frame

Considering that there is no gold standard to measure effect on oxidative stress, established parameters of oxidative stress such as oxidized LDL, malondealdehyde and isoprostane will be measured in plasma and urine. All parameters of oxidative stress before and during treatment with one of both statins will be compared to determine whether atorvastatin causes a stronger and quicker reduction of oxidative stress than simvastatin.

—

Secondary

Measure	Time frame
Niet van toepassing	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)