A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments.
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00462748
First received: April 18, 2007
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Comparator: rosuvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Simvastatin
Atorvastatin calcium
Rosuvastatin calcium
Ezetimibe
Rosuvastatin
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 786 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: Drug
|
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
Other Name: MK0653A
|
|
Active Comparator: 2
Arm 2: Active comparator
|
Drug: Comparator: atorvastatin
atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Other Name: atorvastatin
|
|
Active Comparator: 3
Arm 3: Active comparator
|
Drug: Comparator: rosuvastatin
rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
Other Name: rosuvastatin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
More Information
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00462748 History of Changes |
| Other Study ID Numbers: | 2007_013, MK0653A-121 |
| Study First Received: | April 18, 2007 |
| Results First Received: | May 7, 2009 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Atorvastatin Rosuvastatin Ezetimibe |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013