Trial intelligence / Profile preview

STELLAR: Rosuvastatin vs Atorvastatin, Simvastatin, and Pravastatin in Hypercholesterolemia

NCT00654537Phase 3

Key facts

Status
Completed
Start
Apr 2001
Modality
Orthosteric Ligands
Conditions
hypercholesterolemia
01

Overview

Phase 3, randomised, open-label trial of rosuvastatin in hypercholesterolemia (4 arms), sponsored by AstraZeneca. Primary endpoint: Percentage change in low density lipoprotein cholesterol at 6 weeks. Started Apr 2001; status: completed.

02

Design

4 arms
Study design
RandomizedOpen-label
  • Rosuvastatin

    Rosuvastatin 10, 20, 40, or 80 mg

  • Atorvastatin

    Atorvastatin 10, 20, 40, or 80 mg

  • Pravastatin

    Pravastatin 10, 20, or 40 mg

  • Simvastatin

    Simvastatin 10, 20, 40, or 80 mg

03

Who it enrols

Adults with hypercholesterolemia (LDL-C 160-250 mg/dL) and triglycerides < 400 mg/dL, without active arterial disease.

04

Endpoints

Primary

  • Percentage change in low density lipoprotein cholesterol

Secondary

  • Percentage change in other lipid parameters

  • Safety evaluation

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