Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
1 de junio de 2015 actualizado por: Novartis Pharmaceuticals
A Multi-center, Randomized , Double Blind, Placebo-controlled, Study of the Safety, Tolerability, and Effects on Arterial Structure and Function of ACZ885 in Patients With Clinically Evident Atherosclerosis and Either T2DM or IGT
This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
189
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Mainz, Alemania, 55116
- Novartis Investigative Site
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Neuss, Alemania, 41460
- Novartis Investigative Site
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Ulm, Alemania, 89081
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canadá, H1T 1C8
- Novartis Investigative Site
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New York
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New York, New York, Estados Unidos, 10029
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- Novartis Investigative Site
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Jerusalem, Israel, 91120
- Novartis Investigative Site
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London, Reino Unido, EC1M 6BQ
- Novartis Investigative Site
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UK
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Oxford, UK, Reino Unido, OX2 6HE
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 74 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT
- HbA1c between 6.0% and 10.0%
- On stable statin therapy or statin intolerant
- Patients who are eligible and able to participate in the study
Exclusion Criteria:
- Contraindications to MRI
- NYHA class IV Heart Failure
- NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening
- Patients with type 1 diabetes
- Acute infections
- HsCRP > 30 mg/dL
- Aortic aneurysm ≥5cm
Other protocol-defined inclusion/exclusion criteria may apply
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
subcutaneous (SQ) monthly
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Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
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Experimental: ACZ885
150 mg SQ monthly
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ACZ885 150 mg was administered subcutaneously once a month for 12 months.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Adverse Events, Serious Adverse Events and Death
Periodo de tiempo: 12 months
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Participants were monitored for adverse events, serious adverse events and death throughout the study.
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12 months
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Change From Baseline in Aortic Distensibility
Periodo de tiempo: baseline, 3 months, 12 months
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Two axial, ECG-gated, steady state free precession (SSFP) 'cine' images were acquired during breath-hold to determine aortic distensibility.
The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm.
Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.
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baseline, 3 months, 12 months
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Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)
Periodo de tiempo: baseline, 3 months, 12 months
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For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding.
Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta.
The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans.
For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence.
The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region.
The mean values reported here for the carotid are reported for the proximal common carotid region.
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baseline, 3 months, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
Periodo de tiempo: baseline, 3 months, 12 months
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Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location.
The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.
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baseline, 3 months, 12 months
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Change From Baseline in Plaque Composition
Periodo de tiempo: baseline, 3 months, 12 months
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During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired.
In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.
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baseline, 3 months, 12 months
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Change From Baseline in Aortic Strain
Periodo de tiempo: baseline, 3 months, 12 months
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Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle.
The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..
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baseline, 3 months, 12 months
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Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze hsCRP.
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baseline, 3 months, 12 months
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Change From Baseline in Fasting Plasma Glucose
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze fasting plasma glucose.
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baseline, 3 months, 12 months
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Change From Baseline in Hemoglobin A1c (HbA1c)
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze HbA1c.
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baseline, 3 months, 12 months
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Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze the 2 hour glucose post OGTT.
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baseline, 3 months, 12 months
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Change From Baseline in Beta Cell Function (HOMA-B)
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze beta cell function.
Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 [i.e., HOMA-B = 20*basal insulin/(basal glucose-3.5)].
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baseline, 3 months, 12 months
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Change From Baseline Insulin Resistance (HOMA-IR)
Periodo de tiempo: baseline, 3 months, 12 months
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Blood samples were collected to analyze insulin resistance.
Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 [i.e., HOMA-IR = basal glucose*basal insulin/22.5].
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baseline, 3 months, 12 months
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Pharmacokinetics: ACZ885 Serum Concentrations
Periodo de tiempo: pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12
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Blood samples were collected to analyze the ACZ885 serum concentrations.
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pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2009
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
15 de octubre de 2009
Primero enviado que cumplió con los criterios de control de calidad
15 de octubre de 2009
Publicado por primera vez (Estimar)
16 de octubre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de junio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2015
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CACZ885I2206
- 2009-014618-80
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