A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With a Prior Statin Treatment (IN-CROSS) - IN-CROSS

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2006-005513-35-IT
• Date of registration: 22/05/2007
• Prospective Registration: No
• Primary sponsor: MERCK SHARP DOHME
• Public title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With a Prior Statin Treatment (IN-CROSS) - IN-CROSS
• Scientific title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With a Prior Statin Treatment (IN-CROSS) - IN-CROSS
• Date of first enrolment: 17/04/2007
• Target sample size: 520
• 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: no; Other: no
• 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

Key inclusion & exclusion criteria

Inclusion criteria:
Visit 1

a. Men or women >=18 and <80 years of age,currently taking one of the statins listed below, at one of the specified doses

below, for at least 6 weeks prior to Visit 1 (Week -6)

rosuvastatin 5 mg

simvastatin 20, 40 mg

atorvastatin 10, 20 mg

pravastatin 40 mg

fluvastatin 80 mg

b. LDL-C level >=100 mg/dL (2.50 mmol/L) and <=190 mg/dL (4.9 mmol/L)

c.Patient is willing to maintain an NCEP Therapeutic Lifestyle Changes (TLC)/ADA or

similar cholesterol lowering diet for the duration of the study.

d. Patient has one or more high cardiovascular risk profiles

e. Patient has liver transaminases (ALT and AST) <=1.5 X ULN with no active liver

disease at Visit 2.

f. Patient has creatine kinase (CK) levels <=3 X ULN.

Visit 2.

a.LDL-C level >=100 mg/dL (2.5 mmol/L) and <=160 mg/dL (4.2 mmol/L)

b.Patient has triglyceride (TG) concentrations <=350 mg/dL (3.96 mmol/L)
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:
a. Patient has a hypersensitivity or intolerance to rosuvastatin, ezetimibe or simvastatin

or any component of these medications.

b.Female patient who is pregnant or lactating.

c.Patient has:

-congestive heart failure defined by NYHA (New York Heart Association)

Class III or IV;

- uncontrolled hypertension with systolic blood

pressure >160 mm Hg or diastolic >100 mm Hg at Visit 1

-impaired renal function (creatinine >=2.0 mg/dL)

- endocrine or metabolic disease known to influence serum

lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hypothyroidism,

at Visit 1

-disorders of the hematologic, digestive, or central nervous systems

that would limit study

evaluation or participation.

d.HIV positive

e. takes following medications: potent inhibitors of CYP3A4, other lipid-lowering drugs in the last 6 (eg niacin) or 8 (eg fibrates) precedint visit 1; corticosteroids.


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

Health Condition(s) or Problem(s) studied

hypercholesterolemia and high cardiovascular risk
MedDRA version: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders

Intervention(s)

Trade Name: INEGY
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin and ezetimibe
CAS Number: 79902-63-9
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

Trade Name: PROVISACOR
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosuvastatin
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)

Main Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a

statin and with LDL-Cholesterol blood level (LDL-C) >=100 mg/dL (2.5 mmol/L) and

<=160 mg/dL (4.2 mmol/L) at baseline to assess the additional LDL-C percentage

reduction by switching to ezetimibe/simvastatin (10 mg/20 mg) compared to rosuvastatin

10 mg.

Secondary Objective: In patients with primary hypercholesterolemia and high cardiovascular risk treated with a

statin and with LDL-Cholesterol blood level (LDL-C) >=100 mg/dL (2.5 mmol/L) and

<=160 mg/dL (4.2 mmol/L) at baseline:

1. to determine the percentage of patients reaching LDL-C <100 mg/dL (2.5 mmol/L)

with ezetimibe/simvastatin (10 mg/20 mg) compared to rosuvastatin 10 mg.

2. to determine the percentage of patients reaching LDL-C <70 mg/dL (1.8 mmol/L)

3. to determine the effect of ezetimibe/simvastatin (10 mg/20 mg) compared to

rosuvastatin 10 mg on total cholesterol (TC), triglycerides (TG), high-density

lipoprotein cholesterol (HDL-C), non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C

ratio, Apo-B and C reactive protein (CRP).

4. to evaluate the safety and tolerability of ezetimibe/simvastatin (10 mg/20 mg).

with ezetimibe/simvastatin (10 mg/20 mg) compared to rosuvastatin 10 mg

Primary end point(s): the percentage reduction from baseline in LDL-C at endpoint

Secondary ID(s)

809-00

2006-005513-35-FR

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