A Phase 3 interventional study of Placebo and aleglitazar in Cardiovascular Disease, Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Completed at 393 sites in 27 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,999 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
Exclusion Criteria:
Drug: aleglitazar
Drug: Placebo
matching aleglitazar placebo tablet orally daily
150 mcg orally daily
Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)
Time frame: 5 years
Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
Time frame: 5 years
Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
Time frame: 5 years
Showing the first 100 of 393 sites across 27 countries.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche