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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2006-005513-35-FR |
Date of registration:
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11/01/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10mg/20mg) compared to Rosuvastatin 10mg in patients with primary hypercholesterolemia and high cardiovascular risk and not adequately controlled with a prior statin treatment. (IN-CROSS).
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Scientific title:
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A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10mg/20mg) compared to Rosuvastatin 10mg in patients with primary hypercholesterolemia and high cardiovascular risk and not adequately controlled with a prior statin treatment. (IN-CROSS). |
Date of first enrolment:
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05/02/2007 |
Target sample size:
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1200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005513-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Czech Republic
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Estonia
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France
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Italy
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Latvia
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Lithuania
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Netherlands
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Portugal
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Key inclusion & exclusion criteria
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Inclusion criteria: LDL-C level = 100 mg/dL (2.50 mmol/L) and = 190 mg/dl (4.9 mmol/L) (sample collected at visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Patients with liver or kidney disease Female pregnant or lactating Patient with Heart Failure NYHA Class III and IV Myocradial infarction, coronary arthery by-pass surgery or angioplasthy within 3 months before V1 HBA1c uncontrolled > 8.5 %
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Adjunctive therapy to diet for the reduction of elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia.
MedDRA version: 8.1
Level: HLT
Classification code 10014476
Term: Elevated cholesterol
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Intervention(s)
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Trade Name: Inegy Product Name: Inegy Product Code: MK-0653A Pharmaceutical Form: Tablet INN or Proposed INN: ezetimibe / simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10/20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Crestor Product Name: Crestor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: rosuvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a statin and with elevated LDL-Cholesterol at baseline to assess the additional LDL-C percentage reduction by switching to ezetimibe/simvastatin compared to rosuvastatin.
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Secondary Objective: 1 to determine the percentage of patients reaching LDL-C <100 mg/dL (2.5 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg 2 to determine the percentage of patients reaching LDL-C < 70 mg/dL (1.8 mmol/L) with ezetimibe/simvastatin (10mg/20mg) compared to rosuvastatin 10 mg
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Primary end point(s): LDL cholesterol lowering
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Secondary ID(s)
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MK-0653A Protocol 809-00
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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