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CompletedNCT00654485Updated Mar 16, 2009

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

A Phase 3 interventional study of Rosuvastatin and Atorvastatin in Metabolic Syndrome, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-16.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
940
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

02

Conditions studied

  • Metabolic Syndrome

Keywords

  • Cholesterol
  • hypercholesterolemia
  • low density lipoproteins
  • metabolic syndrome
  • Rosuvastatin
03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's planned enrollment of 940 is above the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
  • Fasting low density lipoprotein cholesterol level of > 130 mg/dL.
  • Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
  • Not previously taken statins.

Exclusion criteria

Exclusion Criteria:

  • The use of lipid lowering drugs or dietary supplements after Visit 1
  • Active arterial disease eg Unstable angina, or recent arterial surgery
  • Blood lipid levels above the limits defined in the protocol
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
940 participants (estimated)

Study arms

  • Experimental
    1

    Rosuvastatin

    Drug: Rosuvastatin

  • Active comparator
    2

    Atorvastatin

    Drug: Atorvastatin

Interventions

06

What researchers measure

Primary outcomes

  1. Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.

    Time frame: At 6 & 12 weeks

Secondary outcomes

  1. Modification of other lipids and lipoproteins

    Time frame: At 6 & 12 weeks

  2. Modification of insulin resistance, inflammatory markers & glucose metabolism

    Time frame: At 6 & 12 weeks

  3. Safety: adverse events & abnormal laboratory markers

    Time frame: At 6 & 12 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2002 and a completion of Feb 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2008
First posted
Apr 8, 2008
Start
May 2002
CompletionActual
Feb 2005
Last update
Mar 16, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00654485
Lead sponsor
AstraZeneca
First posted
Apr 8, 2008
Start date
May 2002
Completion
Feb 2005
Last update
Mar 16, 2009

Study contacts

Prof. Anton Stalenhoef
principal investigator · University Medical Centre, The Netherlands
Russell Esterline
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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