Main
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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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27 January 2014 |
Main ID: |
EUCTR2012-001363-70-HU |
Date of registration:
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11/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to assess the safety and efficacy of AMG-145 on LDL-cholesterol, in combination with Statin therapy in patients with high blood cholesterol or high concentration of lipids in the blood.
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Scientific title:
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A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia |
Date of first enrolment:
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19/11/2012 |
Target sample size:
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1700 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001363-70 |
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: no
Placebo: yes
Other: yes
Other specify the comparator: Ezetimibe
Number of treatment arms in the trial: 24
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Czech Republic
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Denmark
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France
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Germany
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Hong Kong
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Hungary
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Italy
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Korea, Republic of
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Mexico
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Netherlands
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Russian Federation
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Subject has provided informed consent.
• Male or female = 18 to = 80 years of age
• Subjects not taking a statin at screening must have a fasting LDL-C of at least 150 mg/dl (4.0 mmol/L) as determined by central laboratory
• Subjects already on a non-intensive statin (see Appendix D) at screening must have a fasting LDL-C at screening of = 100 mg/dL (2.6 mmol/L) as determined by central laboratory
• Subjects already on a intensive statin (see Appendix D) at screening must have a fasting LDL-C at screening of = 80 mg/dL (2.1 mmol/L) as determined by central laboratory
• Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening 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 1300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria: •Current or prior history of statin intolerance, or any intolerance to rosuvastatin, atorvastatin, or simvastatin.
•Subject, who in the opinion of the investigator, requires maximal statin therapy
•Personal or family history of hereditary muscular disorders
•NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
•Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
•Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 6 months prior to randomization
•Planned cardiac surgery or revascularization
•Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes (within 6 months of randomization), or laboratory evidence of diabetes during screening (fasting plasma glucose = 126 mg/dL [7.0 mmol/L] or HbA1c = 6.5%) without prior diagnosis of diabetes
•Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
•Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, > 1000 mg/day omega-3 fatty acids ( DHA and EPA combined), stanols or prescription lipid-regulating drugs (eg, bileacid sequestering resins, fibrates and derivatives) other than statins and ezetimibe
•Subject has taken a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to LDL-C screening, such as: anacetrapib, dalcetrapib or evacetrapib.Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids (eg, IV, intramuscular [IM], or PO) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane);
(Note: vitamin A in a multivitamin preparation is permitted)
•Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) < 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening
•Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening
•Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening.
•CK > 3 times the ULN at screening
•Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
•Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
•Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse in the past year, inability or unwillingness to adhere to the protocol, or psychosis)
•Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
•Female subject who has either (1) not used at least 1 highly effective method of birth control for at least 1 month prior to screening or
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Primary Hypercholesterolemia and Mixed Dyslipidemia MedDRA version: 14.1
Level: LLT
Classification code 10020604
Term: Hypercholesterolemia
System Organ Class: 100000004861
MedDRA version: 14.1
Level: LLT
Classification code 10058110
Term: Dyslipidemia
System Organ Class: 100000004861
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Product Name: AMG 145 Pharmaceutical Form: Solution for injection Current Sponsor code: AMG 145 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Trade Name: ZETIA® (ezetimibe) Tablets Product Name: ezetimibe Pharmaceutical Form: Tablet INN or Proposed INN: EZETIMIBE CAS Number: 163222-33-1 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
Product Name: Atorvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: atorvastatin CAS Number: 134523-00-5 Other descriptive name: atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Name: Atorvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: atorvastatin CAS Number: 134523-00-5 Other descriptive name: atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80-
Product Name: rosuvastatin Pharmaceutical Form: Tablet INN or Proposed INN: rosuvastatin CAS Number: 287714-41-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: rosuvastatin Pharmaceutical Form: Tablet INN or Proposed INN: rosuvastatin CAS Number: 287714-41-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Name: rosuvastatin Pharmaceutical Form: Tablet INN or Proposed INN: rosuvastatin CAS Number: 287714-41-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
Product Name: simvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: simvastatin CAS Number: 79902-63-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Name: simvastatin Pharmaceutic
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: At week 12
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Main Objective: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 administered every 2 weeks (Q2W) and every 4 weeks (Q4W) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with primary hypercholesterolemia and mixed dyslipidemia.
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Primary end point(s): The primary endpoint is the percent change from baseline in LDL-C at week 12.
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Secondary Objective: • To evaluate the safety and tolerability of SC AMG 145 Q2W and Q4W used in combination with a statin, compared with placebo or ezetimibe, in subjects with primary hypercholesterolemia and mixed dyslipidemia • To assess the effects of 12 weeks of SC AMG 145 Q2W and Q4W used in combination with a statin compared to placebo or ezetimibe, on change from baseline in LDL-C, and percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/ Apolipoprotein A-1 (ApoA1) ratio lipoprotein (a) [Lp(a)], triglycerides and HDLC in subjects with primary hypercholesterolemia and mixed dyslipidemia • To assess the effects of 12 weeks SC AMG 145 Q2W and Q4W compared with ezetimibe, on percent of subjects attaining LDL-C < 70 mg/dL (1.8 mmol/L)
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints
• Change from baseline in LDL-C at week 12
• LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 12
• Percent change from baseline in non-HDL-C at week 12
• Percent change from baseline in ApoB at week 12
• Percent change from baseline in the total cholesterol/HDL-C ratio at week 12
• Percent change from baseline in ApoB/ApoA1 ratio at week 12
• Percent change from baseline in Lp(a) at week 12
• Percent change from baseline in triglycerides at week 12
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Secondary end point(s): Secondary Efficacy Endpoints
Tier 1 endpoints
• Change from baseline in LDL-C at week 12
• LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 12
• Percent change from baseline in non-HDL-C at week 12
• Percent change from baseline in ApoB at week 12
• Percent change from baseline in the total cholesterol/HDL-C ratio at week 12
• Percent change from baseline in ApoB/ApoA1 ratio at week 12
Tier 2 endpoints
• Percent change from baseline in Lp(a) at week 12
• Percent change from baseline in triglycerides at week 12
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Secondary ID(s)
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20110115
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2012-001363-70-ES
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Source(s) of Monetary Support
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Amgen Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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