E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypercholesterolemia, mixed hyperlipidemia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
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 |
1.Evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo on plasma concentrations of LDL-C. 2.To assess the safety and tolerability of anacetrapib (100 mg), particularly with respect to the effects of blood pressure and serum electrolytes (potassium, bicarbonate, sodium and chloride). |
|
E.2.2 | Secondary objectives of the trial |
1. Evaluate the effects of anacetrapib (100 mg) on HDL-C, non HDL-C, Apo-B, and Apo A-I compared to placebo after 24 weeks of treatment. 2. Evaluate effects of anacetrapib (100 mg) on LDL-C, HDL-C, non HDL-C, Apo-B, and Apo A-I compared to placebo after 76 weeks of treatment. 3. Evaluate the effects of anacetrapib (100 mg) on plasma levels of total cholesterol (TC), triglycerides (TG), apo LDL-C/HDL-C, apo B/apo A-1, LDL-C/apo B, lipoprotein (a) [Lp(a)], hsCRP, apo-C-III, A-II, E, and lipoprotein sub- fractions after 24 weeks and 76 weeks of treatment. 4. Evaluate the efficacy of anacetrapib (100 mg) added to different statins (e.g. simvastatin, atorvastatin, pravastatin, rosuvastatin) compared to placebo after 24 weeks and 76 weeks of treatment. 5. Evaluate the effects of cessation of anacetrapib (100 mg) for 12 weeks on LDL-C, HDL-C, TC, and non-HDL-C 6. Evaluate the safety and tolerability of anacetrapib after cessation of treatment
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is male or female and ≥18 and ≤80 years of age on day of signing informed consent.
2. Patient meets one of the following LDL-C criterion based on NCEP ATP III categorization of CHD risk: •Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C <100 mg/dL (2.59 mmol/L). •Patient has multiple risk factors (≥2 RF) with an LDL-C <130 mg/dL (3.37 mmol/L). •Patient is low risk [0-1 RF) with LDL-C <160 mg/dL (4.14 mmol/L)]
3. Patient is treated with statin ± other lipid-modifying therapy and has the following HDL-C criterion: •Patient is high risk (CHD/CHD risk equivalent including diabetes) with HDL-C <60 mg/dL (1.55 mmol/L), in males and females. •Patient has moderate (≥2 RF) or low risk or with HDL-C, (i.e. HDL-C <44 mg/dL (1.14 mmol/L) in males, or HDL-C <54 mg/dL (1.40 mmol/L) in females.
|
|
E.4 | Principal exclusion criteria |
1. Patient has severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV. 2. Patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke MI within 3 months prior to Visit 1. 3. LDL-C <50 mg/dL (1.29 mmol/L). 4. Patient has uncontrolled hypertension defined as follows: •Sitting diastolic blood pressure ≥100 mmHg, or sitting systolic blood pressure ≥160 mm Hg (non-diabetic patients). OR •Sitting diastolic blood pressure ≥90 mmHg, or sitting systolic blood pressure ≥150 mm Hg (diabetic patients).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |