E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027762 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Low density lipoprotein cholesterol [LDL-C] lowering efficacy of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to fenofibrate 160 mg. |
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E.2.2 | Secondary objectives of the trial |
a. Lipid and lipoprotein altering effects (total cholesterol [Total-C], LDL-C, triglyceride [TG], non-high density lipoprotein cholesterol [non-HDL-C], high density lipoprotein cholesterol [HDL-C], very low density lipoprotein cholesterol [VLDL-C], very low density lipoprotein triglyceride [VLDL-TG], and apolipoprotein [apo] B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to ezetimibe/simvastatin 10/20 mg. b. Lipid and lipoprotein altering effects (Total-C, TG, non-HDL-C, HDL-C, VLDL-C, VLDL-TG, apo B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to fenofibrate 160 mg. c. Lipid and lipoprotein altering effects (Total-C, LDL-C, TG, non-HDL-C, HDL-C, VLDL-C, VLDL-TG, apo B, apo A-I) of ezetimibe/simvastatin 10/20 mg and fenofibrate 160 mg coadministration compared to placebo. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a. Patient has an LDL-C 130 through 220 mg/dL (3.37 through 5.70 mmol/L) for non-diabetics; LDL-C 100 through 180 mg/dL (2.59 through 4.66 mmol/L) for diabetics, at Visit 2. b. Patient has triglycerides 150 through 500 mg/dL (1.71 through 5.70 mmol/L). [per central laboratory reference ranges] at Visit 2. c. Patient has creatine phosphokinase (CPK) ≤2 x upper limit of normal (ULN) [per central laboratory reference ranges] at Visit 2. d. Patient has alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN) [per central laboratory reference ranges] at Visit 2.
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E.4 | Principal exclusion criteria |
a. You are less than 18 years of age or greater than 79 years of age. b. You are pregnant, breastfeeding, or planning to become pregnant during this study. c. You are a woman able to become pregnant and are not willing to use an acceptable method of birth control. You must be willing to use this birth control starting at Visit 1 and continuing 14 days past the last study dose. The study doctor or staff will discuss which methods of birth control are acceptable for this study. d. You are a woman and have taken cyclical hormone birth control or hormone replacement within 8 weeks of Visit 3. e. You have chronic heart failure, uncontrolled irregular heart beats or a history of heart disease. The study doctor or staff will discuss this with you. f. You have diabetes and are taking lipid lowering medication called statins. g. You have a history of cholelithiasis (gallbladder problems) and you have not had your gallbladder removed. h. You have an active liver disease. i. You are HIV positive. j. You have a history of cancer with in the past 5 years (except for skin cancer that has been successfully treated). k. You have taken any investigational drug within 30 days of visit 1. l. You have a history of drug or alcohol abuse with in the past 5 years m. You are not willing to stop drinking large amounts of grapefruit juice (more than a quart) a day. n. You have a know allergy or history of side effects to medicines similar to the drugs used in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the percent change from baseline in LDL-C to endpoint after 12 weeks of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Fourteen days after a patient’s visit 5, or after a patient’s final discontinuation visit, a phone call will be performed to assess for safety (new serious adverse experience information for a patient). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |