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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:	EUCTR
Last refreshed on:	30 June 2019
Main ID:	EUCTR2006-005513-35-BE
Date of registration:	25/01/2007
Prospective Registration:	Yes
Primary sponsor:	Merck Sharp & Dohme BV
Public title:	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). - Study to Assess LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin
Scientific title:	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). - Study to Assess LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin
Date of first enrolment:	30/01/2007
Target sample size:	570
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005513-35
Study type:	Interventional clinical trial of medicinal product
Study design:	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: yes Other: yes Other specify the comparator: Rosuvastatin
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Belgium	Czech Republic	Estonia	France	Italy	Latvia	Lithuania	Netherlands
Portugal

Contacts

Name:
Address:
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Affiliation:

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Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hypercholesterolimia
MedDRA version: 8.1 Level: HLT Classification code 10014476 Term: Elevated cholesterol

Intervention(s)

Trade Name: Inegy 10 mg / 20 mg, tablets
Product Name: Inegy
Pharmaceutical Form: Tablet
INN or Proposed INN: ezetimibe/simvastatine
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: Tablet
INN or Proposed INN: rosuvastatine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): LDL cholesterol lowering

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.

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

Secondary Outcome(s)

Secondary ID(s)

2006-005513-35-FR

MK-0653A 809

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:	16/04/2016
Date Completed:	11/03/2008
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005513-35/results

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