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OpenTrials
Completed

NCT Number: NCT00462748

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

ezetimibe (+) simvastatin

Drug

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

Other names: MK0653A

Comparator: atorvastatin

Drug

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

Other names: atorvastatin

Comparator: Rosuvastatin

Drug

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

Other names: rosuvastatin

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 19, 2007
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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