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

A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Metabolic Syndrome, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolic Syndrome
What is being tested?: Rosuvastatin and Atorvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 940 participants
Where: No sites listed yet
Study dates: May 2002to Feb 2005
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

Official title: A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%

Conditions: Metabolic Syndrome
Being tested: Rosuvastatin, Atorvastatin
Keywords: Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin
Medical subject headings: Metabolic Syndrome, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Also called Crestor
AtorvastatinDrug
Also called Lipitor

Study groups in NCT00654485
Study group	Role	What they receive
1	Experimental	Rosuvastatin Receives: Drug: Rosuvastatin
2	Active comparator	Atorvastatin Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
Measured: At 6 & 12 weeks

Secondary outcomes (3)

Modification of other lipids and lipoproteins
Measured: At 6 & 12 weeks
Modification of insulin resistance, inflammatory markers & glucose metabolism
Measured: At 6 & 12 weeks
Safety: adverse events & abnormal laboratory markers
Measured: At 6 & 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2002Feb 2005

First posted8 Apr 2008 (estimated)
Study startMay 2002
Study completionFeb 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 940 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654485
Sponsor's protocol ID: 4522IL/0069
Other IDs: D3560C00069
Status last verified: Mar 2009
First submitted: 3 Apr 2008
Last updated: 16 Mar 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%
ClinicalTrials.gov ID: NCT00654485
Acronym / sponsor ID: 4522IL/0069
Conditions: Metabolic Syndrome
Keywords: Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 940 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2002
Study completion: Feb 2005 (actual)
First posted: 8 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: RosuvastatinRosuvastatin
2	Active comparator	Drug: AtorvastatinAtorvastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAlso: Crestor	Drug	1
AtorvastatinAlso: Lipitor	Drug	2

Primary outcome

Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
Time frame: At 6 & 12 weeks

3 secondary outcomes

Modification of other lipids and lipoproteins
Time frame: At 6 & 12 weeks
Modification of insulin resistance, inflammatory markers & glucose metabolism
Time frame: At 6 & 12 weeks
Safety: adverse events & abnormal laboratory markers
Time frame: At 6 & 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2009.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Anton Stalenhoef principal investigator

University Medical Centre, The Netherlands

Russell Esterline study director

AstraZeneca

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Metabolic Syndrome, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome. (time frame: At 6 & 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00654485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2009.