A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00225589
First received: September 22, 2005
Last updated: November 18, 2010
Last verified: November 2010

September 22, 2005
November 18, 2010
August 2002
May 2006   (final data collection date for primary outcome measure)
Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA
Same as current
Complete list of historical versions of study NCT00225589 on ClinicalTrials.gov Archive Site
  • Assess the effects of rosuvastatin treatment on the following variables, with the same analyses being applied to the IMT variables:
  • Change in the mean maximum IMT of the near & far walls of the right & left CCA, carotid bulb, ICA
  • Change in the mean IMT of the near & far walls of the right & left CCA
  • Change in LDL-C, TC, HDL-C, TG, nonHDL-C, ApoB, ApoA-I, nonHDL-C/HDL-C, & ApoB/ApoA-I
  • Change in inflammatory marker: C-reactive protein (CRP)
  • Safety & tolerability, by evaluating the incidence & severity of adverse events & abnormal laboratory values
Same as current
Not Provided
Not Provided
 
A Study Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin 40 mg (METEOR)
A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR)

The purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Hypercholesteremia
Drug: Rosuvastatin calcium
Other Name: Crestor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Maximum IMT >1.2 mm and 3.5 mm at any location in the carotid ultrasound studies conducted at both Visit 2 (Week -4) and Visit 3 (Week -2)
  • Subjects with age and no other risk factor: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1mmol/L) and <190 mg/dL (4.9 mmol/L)
  • Subjects with 2 or more risk factors and a 10-year coronary heart disease (CHD) risk < 10%: Fasting LDL-C at Visit 1 (Week -6) is >120 mg/dL (3.1 mmol/L) and <160 mg/dL (4.1 mmol/L)

Exclusion Criteria:

  • Use of pharmacologic lipid-lowering medications (eg, HMG-CoA reductase inhibitors, fibrate derivatives, bile acid binding resins, niacin or its analogues at doses >400 mg) within 12 months prior to Visit 1 (Week -6).
  • Clinical evidence of coronary artery disease or any other atherosclerotic disease such as angina, MI, TIA, symptomatic carotid artery disease, CVA, CABG, PTCA, peripheral arterial disease, AAA.
Both
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   Finland,   France,   Germany,   Netherlands,   Norway
 
NCT00225589
4522IL/0088, METEOR, D3562C00088
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Crestor Medical Science Director, MD AstraZeneca
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP