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CompletedNCT00654537STELLARUpdated Mar 16, 2009

STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

A Phase 3 interventional study of Rosuvastatin and Atorvastatin in Hypercholesterolemia, 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
5,625
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • Cholesterol
  • hypercholesterolemia
  • low density lipoproteins
03

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's planned enrollment of 5,625 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia 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

  • Discontinuation of all previous lipid lowering therapy.
  • Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1.
  • Other lipid parameters as specified in the protocol.

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
  • Abnormal laboratory parameters as defined in the protocol.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,625 participants (estimated)

Study arms

  • Experimental
    1

    Rosuvastatin

    Drug: Rosuvastatin

  • Active comparator
    2

    Atorvastatin

    Drug: Atorvastatin

  • Active comparator
    3

    Pravastatin

    Drug: Pravastatin

  • Active comparator
    4

    Simvastatin

    Drug: Simvastatin

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage change in low density lipoprotein cholesterol.

    Time frame: 4 & 6 weeks

Secondary outcomes

  1. Percentage change in other lipid parameters as defined by the protocol

    Time frame: 6 weeks

  2. Safety evaluation

    Time frame: 6 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 Apr 2001 and a completion of Oct 2004. 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
Apr 2001
CompletionActual
Oct 2004
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
NCT00654537
Lead sponsor
AstraZeneca
First posted
Apr 8, 2008
Start date
Apr 2001
Completion
Oct 2004
Last update
Mar 16, 2009

Study contacts

Eleanor Miller, MD
study director · AstraZeneca
Russell Esterline
study chair · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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