E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 |
Different types of lipoproteins have varied significance on cardiovascular disease. Low-density lipoproteins (LDL) are carriers of cholesterol. Excess cholesterol becomes deposited in blood vessel walls. The blood vessels are narrowed as a result and blood flow becomes compromised. When LDL is oxidised (combined with oxygen) or glycated (bound to glucose), the structure is altered. Altered LDL acts as a direct irritant to the vessel wall causing inflammation. Eventually the inflammatory damage to the blood vessels cannot be repaired. High-density lipoproteins (HDL) have a protective role in cardiovascular disease. HDL takes up cholesterol in the circulation and carries it to the liver where it is broken down. HDL is associated with an enzyme paraoxonase. The enzyme is thought to have an important role in preventing LDL from oxidation and glycation thus reducing its ability to be inflammatory.
Therefore too much LDL is harmful to the body but high levels of HDL are advantageous. Dru |
|
E.2.2 | Secondary objectives of the trial |
HDL is associated with the enzyme paraoxonase. The enzyme is thought to have an important role in preventing LDL oxidation and glycation. We will study the effects of tredaptive on levels of paraoxonase activity, oxidised LDL, glycated LDL and various markers of inflammation: e.g. cell adhesion molecules, serum amyloid A, hcCRP (C-reactive protein), TNF-alpha (tumour necrosis factor-alpha). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men and women who are taking cholesterol-lowering medication (maximum tolerated statins and/or ezetimibe) and who have not reached the recommended LDL target of less than 1.8 mmol/l (70 mg/l). Ezetimibe will be stopped 4 weeks before entering the study. |
|
E.4 | Principal exclusion criteria |
Pregnant and/or breast-feeding women. Significant renal impairment (eGFR < 59ml/min). Active liver disease and transaminases > 3 times upper limit of normal range. Patients on fibrates. Patients on Omacor. Patients who are allergic to nicotinic acid. |
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E.5 End points |
E.5.1 | Primary end point(s) |
We expect the majority (90% or more) of patients to achieve a 15% increase in HDL level. |
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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 | Yes |
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 | Yes |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
The last visit of the last subject is defined as the end of the trial. |
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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 | 14 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |