ROMEO (Rosuvastatin in Metabolic syndrOme)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Metabolic Syndrome X

Treatments: Drug: Atorvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395486

ROMEO

D3560L00061

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

Rosuvastatin

Experimental group

Treatment:

Drug: Rosuvastatin

Atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin