E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease |
|
E.1.1.1 | Medical condition in easily understood language |
Risk of heart attacks and stroke |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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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 |
Main Objective:
In patients with CHD/CHD risk-equivalent disease who were previously treated with anacetrapib during the DEFINE P019 study:
To assess the plasma levels of anacetrapib remaining in patients who were previously treated with anacetrapib |
|
E.2.2 | Secondary objectives of the trial |
Exploratory Objective:
To assess LDL-C and HDL-C levels in patients who were previously treated with anacetrapib |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. DEFINE study patients who took at least one dose of anacetrapib and are not currently enrolled in the ongoing PN 019-12 study.
2. Patients who have completed or discontinued from the PN 019-12 study.
3. Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent. |
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E.4 | Principal exclusion criteria |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability of anacetrapib 100 mg;
elevations in safety laboratory variables
elevations in blood pressure
myalgia, rhabdomyolysis
Pre-specified adjudicated CV serious adverse events
Death |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Following 104 weeks of the 2-year extension. |
|
E.5.2 | Secondary end point(s) |
LDL-C, HDL-C, non-HDL-C, apo-B, apo A-I, TC, TG, TC/HDLC,
LDL-C/HDL-C , LDL-C/Apo B, Apo B/ ApoA-I, lp(a), apo E , CETP mass, CETP activity and hsCRP, and percent change from baseline (Day 0; Visit 3 in the base study) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Following 104 weeks of the 2-year extension. |
|
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 | No |
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 |
Australia |
Austria |
Canada |
Colombia |
Finland |
France |
Germany |
Hong Kong |
Hungary |
Malaysia |
Netherlands |
New Zealand |
Norway |
Spain |
Sweden |
Israel |
Peru |
Russian Federation |
|
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
|
last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |