ROMEO (Rosuvastatin in Metabolic syndrOme)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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

The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease

NCT00235950

Coronary Heart Disease

COMPLETED PHASE4

Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

NCT00335699

Hypercholesterolemia

COMPLETED PHASE4

COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

NCT00654485

Metabolic Syndrome

COMPLETED PHASE3

STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

NCT00654537

Hypercholesterolemia

COMPLETED PHASE3

The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease

NCT02516826

Coronary Syndrome

UNKNOWN PHASE2

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.

Metabolic Syndrome X

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

NONE

Study Groups

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

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

10mg

Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

10mg

Interventions

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

Rosuvastatin

10mg

Intervention Type DRUG

Atorvastatin

10mg

Intervention Type DRUG

Other Intervention Names

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

Crestor

Eligibility Criteria

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

Inclusion Criteria

* Presence of 3 or more of the following criteria;

* Abdominal obesity (men \>90cm women \>80cm)
* Triglycerides ≥ 150 mg/dL
* HDL-C: men \< 40 mg/dL, women \< 50 mg/dL
* BP ≥130/≥85 mmHg or anti-hypertensive treatment
* Fasting blood glucose ≥100 mg dL or anti-diabetic treatment
* Elevated LDL-C ;

* ≥130 mg/dL to \< 220 mg/dL in lipid lowering agent naive subjects
* ≥100 mg/dL to \< 200 mg/dL in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1.
* Triglyceride \< 500 mg/dL

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No