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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462748
• Other study ID #: 0653A-121
• Secondary ID: MK0653A-1212007_
• Status: Completed
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 786
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
• Comparator: atorvastatin
atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
• Comparator: rosuvastatin
rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Weeks