A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome ... | Completed
A Study With Aleglitazar in Patient... | Completed
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

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Medical Conditions
  • Diabetes Mellitus Type 2
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01042769

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Aleglitazar, Drug : Placebo

Study Arm Groups : Aleglitazar, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; Throughout study, approximately 4.5 years
Secondary Outcome Measures
    Effects on other cardiovascular endpoints; Throughout study, approximately 4.5 years; Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk; Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter; Tolerability and long-term safety profile; Throughout study, approximately 4.5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Adults >18 years of age

    - Type 2 diabetes mellitus

    - Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

    Exclusion Criteria:

    - Estimated glomerular filtration rate <45 mL/min/1.73m2

    - Concomitant treatment with a thiazolidinedione and/or fibrate

    - Triglycerides >400 mg/dL

    - Anaemia

    - Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Oxford Road
Manchester
M13 9WL
West Middlesex University Hospital
Isleworth
England
TW7 6AF
GSK Investigational Site
Cambridge
CB2 0QQ
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Rheumatology Department, Poole Hospital NHS Trust
Poole
BH15 2JB
Plymouth
PL6 8BX
Northampton
NN1 5BD
Barts and The London Hospital
London
E1 2AT
Romford
Essex
RM7 0AG
Basildon University Hospital
Basildon
England
SS16 5NL
Royal United Hospital
Bath
England
BA1 3NG
City Hospital - Birmingham
West Bromwich
England
B71 4HJ
Craigavon Area Hospital
Craigavon
Northern Ireland
BT63 5QQ
Leeds
GSK Investigational Site
Derby
DE22 3DT
Pfizer Investigational Site
Brighton
BN2 1ES
Harrow
HA1 3UJ
GSK Investigational Site
Antrim
BT41 2RL
Ayr Hospital
Ayr
Scotland
KA6 6DX
Belfast
BT13 3BW
Ealing Hospital
Southall
London
UB1 3HW
BT47 6SB
G11 6NK
35031
Inverness
IV2 4RE
Cowes
30 5TG.
London
W2 1LA
Stoke-on-Trent
ST4 6QG
Wrexham
LL137TD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Australia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Grenada, Hungary, India, Ireland, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Sweden, Thailand, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
BC22140
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Feb 2010

Recruitment End Date

Nov 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 Jan 2010

Date updated in source

01 Sep 2016