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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ezetimibe (+) simvastatin

Comparator: atorvastatin

Comparator: rosuvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Arm 1: Drug

Arm 2: Active comparator

Arm 3: Active comparator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00462748

First Posted

April 18, 2007

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00462748

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

786 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm 1: Drug

Arm Title

Arm Type

Active Comparator

Arm Description

Arm 2: Active comparator

Arm Title

Arm Type

Active Comparator

Arm Description

Arm 3: Active comparator

Intervention Type

Drug

Intervention Name(s)

ezetimibe (+) simvastatin

Other Intervention Name(s)

MK0653A

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: atorvastatin

Other Intervention Name(s)

atorvastatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: rosuvastatin

Other Intervention Name(s)

rosuvastatin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

20487050

Citation

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.

Results Reference

derived

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

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