Trial intelligence / Profile preview

Rosuvastatin in Visceral Adiposity

2005-001048-22Phase 2

Key facts

Status
Completed
Start
Aug 2005
Countries
1
Sponsor
University of Gothenburg
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Conditions
Abdominal adiposity (ABCD)dyslipidemia
01

Overview

Phase 2, randomised, double-blind trial in Abdominal adiposity (ABCD) and dyslipidemia comparing Rosuvastatin with Placebo (2 arms). Primary endpoint: Change in intra-abdominal adipose tissue area. Started Aug 2005; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Rosuvastatin

    Participants received rosuvastatin in a double-blind parallel-group design.

  • Placebo

    Participants received placebo in a double-blind parallel-group design.

03

Who it enrols

Adult men aged 40 to 65 years with abdominal obesity defined by waist circumference at least 102 cm and dyslipidemia were eligible. Patients with uncontrolled hypertension, diabetes mellitus, severe liver disease, severe renal impairment, endocrine disorders, malignant disease, myopathic disease, substance abuse, or ongoing treatment with statins, anti-obesity drugs, anti-inflammatory drugs, or immunosuppressive drugs were excluded.

04

Endpoints

Primary

  • Change in intra-abdominal adipose tissue area

Secondary

  • Fatty infiltration in the liver

  • Muscle attenuation values

  • Glycemia

  • Lipid levels

  • Gene expression in subcutaneous adipose tissue

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