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CompletedNCT00654173SOLARUpdated Mar 16, 2009

Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

A Phase 3 interventional study of Rosuvastatin and Simvastatin 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
4,444
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • Cholesterol
  • low density lipoproteins
  • dyslipidaemia
  • Rosuvastatin
  • Crestor
  • Atorvastatin
  • Lipitor
  • Zocor
  • simvastatin
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 4,444 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

Inclusion criteria

  • Member of managed care plan for hypercholesterolemia
  • Fasting blood lipid levels as defined by the protocol
  • Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease

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
None (open label)
Enrollment
4,444 participants (actual)

Study arms

  • Experimental
    1

    Rosuvastatin

    Drug: Rosuvastatin

  • Active comparator
    2

    Simvastatin

    Drug: Simvastatin

  • Active comparator
    3

    Atorvastatin

    Drug: Atorvastatin

Interventions

  • DrugRosuvastatin

    Also known as: Crestor

  • DrugSimvastatin

    Also known as: Zocor

  • DrugAtorvastatin

    Also known as: Lipitor

06

What researchers measure

Primary outcomes

  1. Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.

    Time frame: 6 weeks

Secondary outcomes

  1. Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin

    Time frame: 6 & 12 weeks

  2. Safety: adverse events & abnormal laboratory markers

    Time frame: 6 & 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
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
NCT00654173
Lead sponsor
AstraZeneca
First posted
Apr 7, 2008
Start date
Jun 2002
Completion
Sep 2004
Last update
Mar 16, 2009

Study contacts

Alex Gold, MD
principal investigator · AstraZeneca
Russell Esterline
study director · 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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