Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients

Phase 1

• Conditions: atherosclerosis type 2 diabetes mellitus(T2DM); MedDRA version: 13.1 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 13.1 Level: LLT Classification code 10003601 Term: Atherosclerosis System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2009-014618-80-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-04
• Study Completion: 2014-02-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 189

Inclusion Criteria

-Patients with known atherosclerotic disease and documented diagnosis of T2DM for = 14 years OR IGT
-HbA1c between 6.0% and 10%
-On stable statin therapy or statin intolerant
-Patients who are eligible and able to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified