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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01715818




Registration number
NCT01715818
Ethics application status
Date submitted
25/10/2012
Date registered
29/10/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
Scientific title
A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
Secondary ID [1] 0 0
2012-000671-16
Secondary ID [2] 0 0
BC28027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease, Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - aleglitazar

Experimental: Aleglitazar -

Placebo Comparator: Placebo -


Treatment: Drugs: Placebo
matching aleglitazar placebo tablet orally daily

Treatment: Drugs: aleglitazar
150 mcg orally daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
- Male and female patients with established evidence of stable cardiovascular disease
(CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/=
40 years with history with prior CV event of prior myocardial infarction or prior
ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to
randomization and stable in the Investigator's judgment B. Age >/= 55 years with
evidence of CVD (stable in the Investigator's judgment), defined as at least one of
the following: Coronary disease, cerebrovascular disease or peripheral arterial
disease as defined by protocol

- Patients with glucose abnormalities based on one of the following A-B criteria:

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

- Optimal management of CV risk factors including hypertension and dyslipidemia as
informed by the best evidence and clinical practice guidelines
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current treatment with a thiazolidinedione (TDZ) or fibrate

- Prior intolerance to a TDZ or fibrate

- Previous participation in a trial with aleglitazar

- Other types of diabetes

- Inadequate liver, hematologic or renal function

- Symptomatic heart failure classified as NYHA class II-IV

- Hospitalization for a primary diagnosis of heart failure in the 12-month period
preceding randomization

- Peripheral edema which in the judgment of the Investigator in believed to be severe
and of cardiac origin

- History of surgical coronary revascularization (CABG) less than 5 years prior to
screening, except in cases of subsequent myocardial infarction

- Currently scheduled for arterial revascularization procedures

- Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening

- Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ
carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
1999
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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- Camperdown
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- Gosford
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- Kogarah
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- Wollongong
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- South Brisbane
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- Adelaide
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- Heidelberg
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- Melbourne
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- Armadale
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- Perth
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2050 - Camperdown
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2250 - Gosford
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2217 - Kogarah
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2500 - Wollongong
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4101 - South Brisbane
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5011 - Woodville
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3081 - Heidelberg
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3004 - Melbourne
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6112 - Armadale
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6009 - Perth
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Soham, Ely

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01715818
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01715818