Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
1. Juni 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
189
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Mainz, Deutschland, 55116
- Novartis Investigative Site
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Neuss, Deutschland, 41460
- Novartis Investigative Site
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Ulm, Deutschland, 89081
- Novartis Investigative Site
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Jerusalem, Israel, 91120
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Kanada, H1T 1C8
- Novartis Investigative Site
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New York
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New York, New York, Vereinigte Staaten, 10029
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45219
- Novartis Investigative Site
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London, Vereinigtes Königreich, EC1M 6BQ
- Novartis Investigative Site
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UK
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Oxford, UK, Vereinigtes Königreich, OX2 6HE
- Novartis Investigative Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 74 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Placebo-Komparator: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Participants With Adverse Events, Serious Adverse Events and Death
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2009
Primärer Abschluss (Tatsächlich)
1. Februar 2014
Studienabschluss (Tatsächlich)
1. Februar 2014
Studienanmeldedaten
Zuerst eingereicht
15. Oktober 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Oktober 2009
Zuerst gepostet (Schätzen)
16. Oktober 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. Juni 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juni 2015
Zuletzt verifiziert
1. Juni 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CACZ885I2206
- 2009-014618-80
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