Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

NCT ID: NCT01424891

Last Updated: 2011-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Treatment with placebo over 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

treatment with placebo over 8 weeks

Simvastatin 80 mg

treatment with 80 mg of simvastatin over 8 weeks

Group Type ACTIVE_COMPARATOR

Simvastatin 80 mg

Intervention Type DRUG

treatment with 80 mg of simvastatin over a period of 8 weeks

Sim10/Eze10

treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks

Group Type ACTIVE_COMPARATOR

Sim10/Eze10

Intervention Type DRUG

treatment with combination of simvastatin 10 mg and ezetimibe 10 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simvastatin 80 mg

treatment with 80 mg of simvastatin over a period of 8 weeks

Intervention Type DRUG

Sim10/Eze10

treatment with combination of simvastatin 10 mg and ezetimibe 10 mg

Intervention Type DRUG

Placebo

treatment with placebo over 8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

zocor simvastatin inegy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 35 to 80 years old
* type 2 diabetes
* HbA1c value between 6.0 % and 9.0 %
* elevated LDL-c values \> 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion Criteria

* refused informed consent
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gottfried Rudofsky

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gottfried Rudofsky, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heidelberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Heidelberg

Heidelberg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SimEze

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ezetrol Post-Marketing Study
NCT00753883 COMPLETED PHASE4