HypercholesterolemiaPhase 3NCT00462748

A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

A Phase 3 study testing ezetimibe (+) simvastatin, Comparator: atorvastatin and Comparator: rosuvastatin in people with Hypercholesterolemia, run by Organon and Co.

Completed

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

Official record

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Trial summary

To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6 weeks treatment with either… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: ezetimibe (+) simvastatin, Comparator: atorvastatin and Comparator: rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 786 participants
Where: No sites listed yet
Study dates: Mar 2007to Jun 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient Is Male Or Female And Aged Over 18
Patient Provides Written Informed Consent
Patient Has A Fasting Ldl-C Level >2mmol/L At Both Visit 1 And Again At Visit 2
Patient Has Established Cvd, Diabetes Or At "High Risk" Of Cvd (>20 % Risk Over 10 Years, Framingham Scale)
Patient Has Taken Simvastatin 40mg Continuously For The Past 6 Weeks
Patient Has A Fasting Triglyceride Level Of <3.7mmol/L
Patient Has Hba1c <9% At Visit 1
Patient Is 75% Compliant With Medication Between Visit 1 And Visit 2

Who cannot join

Patient Is Hypersensitive To Any Of The Study Medications Or Their Components
Patient Has A History Of, Or Active Liver Disease (Persistent Elevation Of Alt / Ast (>3xuln)
Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception
Patient Has Severe Renal Impairment: Creatinine Clearance <30ml/Min (Cockcroft-Gault Equation) (In Patients With Moderate Renal Impairment: <60ml/Min, The Dose Of Rosuvastatin Will Be 5mg In Line With The Spc)
Patient Has Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoproteins (I.E. Secondary Causes Of Hyperlipidaemia Such As Hypothyroidism Or Hyperthyroidism)
Patient Has A Recent History Of, Or Current, Alcohol Abuse

Show all 9Show fewer

Patient Has Ck >10 X Uln At Visit 1 Or Visit 2
Patient Has Fasting Ldl-C >4.2mmol/L
Patient Has Any Acute Or Serious Condition, Or History Suggestive Of Myopathy Or Predisposing To The Development Of Renal Failure Secondary To Rhabdomyolysis (E.G. Sepsis, Hypotension, Major Surgery, Trauma, Severe Metabolic, Severe Endocrine And Electrolyte Disorders Or Uncontrolled Seizures)

About this study

Official title: A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l

Conditions: Hypercholesterolemia
Being tested: ezetimibe (+) simvastatin, Comparator: atorvastatin, Comparator: rosuvastatin
Medical subject headings: Hypercholesterolemia

What participants receive

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

ezetimibe (+) simvastatinDrug
Also called MK0653A
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
Comparator: atorvastatinDrug
Also called atorvastatin
atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Comparator: rosuvastatinDrug
Also called rosuvastatin
rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

Study groups in NCT00462748
Study group	Role	What they receive
1	Experimental	Arm 1: Drug Receives: Drug: ezetimibe (+) simvastatin
2	Active comparator	Arm 2: Active comparator Receives: Drug: Comparator: atorvastatin
3	Active comparator	Arm 3: Active comparator Receives: Drug: Comparator: rosuvastatin

What is being measured

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

Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.
Measured: 6 Weeks

Timeline

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

Mar 2007Jun 2008

First posted19 Apr 2007 (estimated)
Study startMar 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
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
Who is masked: Participant, Investigator
Enrolment: 786 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00462748
Sponsor's protocol ID: 0653A-121
Other IDs: MK0653A-121, 2007_013
Status last verified: Feb 2022
First submitted: 18 Apr 2007
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

McCormack T, Harvey P, Gaunt R, Allgar V, Chipperfield R, Robinson P; IN-PRACTICE study. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets. Int J Clin Pract. 2010 Jul;64(8):1052-61. doi: 10.1111/j.1742-1241.2010.02429.x. Epub 2010 May 12.
PubMed 20487050

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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l
ClinicalTrials.gov ID: NCT00462748
Acronym / sponsor ID: 0653A-121
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 786 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 19 Apr 2007 (estimated)
Results: Posted 17 Aug 2009

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 (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: ezetimibe (+) simvastatinArm 1: Drug
2	Active comparator	Drug: Comparator: atorvastatinArm 2: Active comparator
3	Active comparator	Drug: Comparator: rosuvastatinArm 3: Active comparator

Who may qualify

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

Key inclusion criteria (8 listed)

Patient Is Male Or Female And Aged Over 18
Patient Provides Written Informed Consent
Patient Has A Fasting Ldl-C Level >2mmol/L At Both Visit 1 And Again At Visit 2
Patient Has Established Cvd, Diabetes Or At "High Risk" Of Cvd (>20 % Risk Over 10 Years, Framingham Scale)
Patient Has Taken Simvastatin 40mg Continuously For The Past 6 Weeks

Key exclusion criteria (9 listed)

Patient Is Hypersensitive To Any Of The Study Medications Or Their Components
Patient Has A History Of, Or Active Liver Disease (Persistent Elevation Of Alt / Ast (>3xuln)
Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception
Patient Has Severe Renal Impairment: Creatinine Clearance <30ml/Min (Cockcroft-Gault Equation) (In Patients With Moderate Renal Impairment: <60ml/Min, The Dose Of Rosuvastatin Will Be 5mg In Line With The Spc)
Patient Has Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoproteins (I.E. Secondary Causes Of Hyperlipidaemia Such As Hypothyroidism Or Hyperthyroidism)

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
ezetimibe (+) simvastatinAlso: MK0653Aezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.	Drug	1
Comparator: atorvastatinAlso: atorvastatinatorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally	Drug	2
Comparator: rosuvastatinAlso: rosuvastatinrosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.	Drug	3

Primary outcome

Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
Time frame: 6 Weeks
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.

Results and safety

Results posted to the registry on 17 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe/Simvastatin	261	249
Atorvostatin	263	252
Rosuvastatin	262	251

Primary outcome: Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End

Time frame: 6 Weeks. Number. Unit: Percent

Measure	Ezetimibe/Simvastatin n = 255	Atorvostatin n = 259	Rosuvastatin n = 258
Value	67.4	36.3	17.4

Ezetimibe/Simvastatin vs Atorvostatin: p <0.001, Regression, Logistic
Ezetimibe/Simvastatin vs Rosuvastatin: p <0.001, Regression, Logistic

Population analysed: The Full Analysis Set (FAS) all patients who were: * Randomised * Took at least one dose of double-blind medication * Had a baseline measurement of efficacy * Had a post-baseline measurement of efficacy Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe/Simvastatin	4 of ?	6 of ?	Not reported
Atorvostatin	2 of ?	1 of ?	Not reported
Rosuvastatin	4 of ?	8 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20487050McCormack T, Harvey P, Gaunt R, Allgar V, Chipperfield R, Robinson P; IN-PRACTICE study. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets. Int J Clin Pract. 2010 Jul;64(8):1052-61. doi: 10.1111/j.1742-1241.2010.02429.x. Epub 2010 May 12.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ezetimibe (+) simvastatin, Comparator: atorvastatin and Comparator: rosuvastatin in people with Hypercholesterolemia, run by Organon and Co.

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 8 inclusion and 9 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 May 2024. 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?

Yes. Results are posted in the registry (first posted 17 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End (time frame: 6 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 NCT00462748, which also lists 1 linked publication.

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 May 2024.