CClinicalTrials.gg
Sign In
CompletedNCT00462748Updated May 16, 2024Results posted

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

A Phase 3 interventional study of ezetimibe (+) simvastatin and Comparator: atorvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
786
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

02

Conditions studied

  • Hypercholesterolemia
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 786 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) 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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
786 participants (actual)

Study arms

  • Experimental
    1

    Arm 1: Drug

    Drug: ezetimibe (+) simvastatin

  • Active comparator
    2

    Arm 2: Active comparator

    Drug: Comparator: atorvastatin

  • Active comparator
    3

    Arm 3: Active comparator

    Drug: Comparator: rosuvastatin

Interventions

  • Drugezetimibe (+) simvastatin

    ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.

    Also known as: MK0653A

  • DrugComparator: atorvastatin

    atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally

    Also known as: atorvastatin

  • DrugComparator: rosuvastatin

    rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

    Also known as: rosuvastatin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 Weeks

07

Results

Posted Aug 17, 2009

Participant flow

Patients with diabetes, cardiovascular disease (CVD) or a "high risk" of developing CVD and a fasting LDL-C level of ≥2mmol/l, having been on simvastatin 40mg for 6 weeks were assigned to 10/40 mg ezetimibe/simvastatin; 40 mg atorvastatin; 10 mg rosuvastatin (5 mg in elderly/Asian patients (in line with UK SPC)) between 27/03/2007 and 31/03/2008

Participant flow — Overall Study
MilestoneEzetimibe/SimvastatinAtorvostatinRosuvastatin
Started261263262
Completed249252251
Not completed121111
Withdrew: Adverse event759
Withdrew: Protocol violation021
Withdrew: Withdrew consent330
Withdrew: Lost to follow-up111
Withdrew: Discontinued after 41 days rx100

Outcome measures

PrimaryPercentage 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.

Time frame:
6 Weeks
Reported as:
Number · Percent
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
PercentEzetimibe/SimvastatinAtorvostatinRosuvastatin
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End67.436.317.4
Statistical analysis
  • Ezetimibe/Simvastatin vs Atorvostatin · Regression, Logistic · p = <0.001 (Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.)The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.
  • Ezetimibe/Simvastatin vs Rosuvastatin · Regression, Logistic · p = <0.001 (Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.)The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ezetimibe/Simvastatin———
Atorvostatin———
Rosuvastatin———
Most frequent serious events
Most frequent serious events
EventEzetimibe/SimvastatinAtorvostatinRosuvastatin
Platelet count decreasedInvestigations1/2590/2600/261
Aortic regurgitationCardiac disorders1/2590/2600/261
Chest painGeneral disorders1/2590/2600/261
Oesophageal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2590/2600/261
Erthematous rashSkin and subcutaneous tissue disorders0/2591/2600/261
Areterial haemorrhageVascular disorders0/2591/2600/261
Rectal bleedingGastrointestinal disorders0/2590/2601/261
HydronephrosisRenal and urinary disorders0/2590/2601/261
Bladder neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2590/2601/261
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders0/2590/2601/261
Most frequent other events
Most frequent other events
EventEzetimibe/SimvastatinAtorvostatinRosuvastatin
DiarrheaGastrointestinal disorders6/2591/2608/261

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ezetimibe/SimvastatinAtorvostatinRosuvastatinTotal
Mean64.7 ± 8.6564.2 ± 8.4463.9 ± 8.6164.3 ± 8.56
Age, Customized
Age, Customized(participants)Ezetimibe/SimvastatinAtorvostatinRosuvastatinTotal
< 70 years185187195567
>=70 years767667219
Sex: Female, Male
Sex: Female, Male(Participants)Ezetimibe/SimvastatinAtorvostatinRosuvastatinTotal
Female1017884263
Male160185178523
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Ezetimibe/SimvastatinAtorvostatinRosuvastatinTotal
Asian3025
White254261257772
Black4026
Other0213
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00462748
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Apr 19, 2007
Start date
Mar 2007
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Aug 17, 2009
Last update
May 16, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercholesterolemia→

Other studies from this sponsor

Organon and Co

Start the discussion