E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with stable CHD, CHD risk equivalents (including PAD, cerebrovascular disease, and T2D), or at elevated risk for CV mortality and morbidity on the basis of multiple risk factors for CVD by raising HDL-C. |
Pacientes con Carciopatía Coronaria estable, equivalentes de riesgo de CC (incluyendo EAP, enf. Cerebrovascular , y DT2) o con riesgo elevado de morbimortalidad CV basado en múltiples factores de riesgo por ECV aumentando HDL-C |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with Cardiovascular disease or at elevated risk of developing cardiovascular disease. |
Pacientes con Enfermedad CV o con riesgo elevado de desarrollar Enfermedad CV |
|
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 | PT |
E.1.2 | Classification code | 10007649 |
E.1.2 | Term | Cardiovascular disorder |
E.1.2 | System Organ Class | 10007541 - Cardiac 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 |
To evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in adult patients with stable coronary heart disease (CHD), CHD risk equivalents or at elevated risk for cardiovascular disease (CVD) |
evaluar el potencial de dalcetrapib para reducir la morbimortalidad cardiovascular en pacientes adultos con cardiopatía coronaria (CC) estable, equivalentes de riesgo de CC o con riesgo elevado de enfermedad cardiovascular (ECV) |
|
E.2.2 | Secondary objectives of the trial |
- To assess the long term safety and tolerability of dalcetrapib |
evaluar la seguridad y la tolerabilidad de dalcetrapib a largo plazo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients ?45 years of age with stable CHD, CHD risk equivalents or at elevated risk for CVD, receiving evidence-based medical therapy for dyslipidemia. |
Pacientes adultos ?45 años de edad con CC estable, equivalentes de riesgo de CC o con riesgo elevado de ECV, recibiendo terapia medica basada en la evidencia para dislipidemia |
|
E.4 | Principal exclusion criteria |
. Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization. . Uncontrolled hypertension. . Uncontrolled diabetes. . Concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates, bile acid sequestrants) or drugs other than dalcetrapib. . Previous treatment with compounds targeting CETP, e.g. torcetrapib, anacetrapib or dalcetrapib. |
Aparición de infarto de miocardio, hospitalización por angina inestable, accidente cerebrovascular o revascularización (coronaria, carotídea o periférica) en el plazo de los tres meses anteriores a la aleatorización. Hipertensión no controlada Diabetes no controlada Tratamiento concomitante con cualquier otro fármaco para aumentar el HDL-C (Ej.niacina, fibratos,secuestradores de ácidos biliares) u otros fármacos distintos de dalcetrapib. Tratamiento previo con compuestos dirigidos contra la PTEC, como p. ej. torcetrapib, anacetrapib o dalcetrapib |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity). |
el tiempo hasta la primera aparición de cualquiera de los componentes del criterio de valoración compuesto del acontecimiento cardiovascular (morbilidad y mortalidad cardiovascular) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Fin del estudio |
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E.5.2 | Secondary end point(s) |
? All cause mortality. ? Change from baseline in blood lipids and lipoprotein levels. ? Adverse events, lab parameters, vital signs. |
Mortalidad por todas las causas Cambio desde el inicio para los niveles de lípidos en sangre y lipoproteínas. Acontecimientos adversos, parámetros de laboratorio, signos vitales. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Fin del estudio |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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 | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 211 |
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 |
Brazil |
Bulgaria |
Canada |
China |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
India |
Israel |
Mexico |
Netherlands |
Poland |
Russian Federation |
Spain |
Taiwan |
Ukraine |
United Kingdom |
United States |
|
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 patient last visit or last received data point, whichever is the latest. |
Ultima visita del ultimo paciente, o ultimo dato recibido, lo que ocurra mas tarde |
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |