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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Diabetes Mellitus, Type 2
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01042769
Primary Trial ID Number
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 : 1, 2

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
This is available on the Clinicaltrials.gov website
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 <45mL/min/1.73m2
  • - Concomitant treatment with a thiazolidinedione and/or fibrate
  • - Triglycerides >400 mg/dL
  • - Anaemia
  • - Symptomatic congestive heart failure classified as 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
Trial Location(s)
Royal United Hospital NHS Trust
Bath
Somerset
BA1 3NG
Research Site
Harrow
HA1 3UJ
Manchester Royal Infirmary
Manchester
England
M13 9WL
Addenbrookes Hospital
Cambridge
CB2 0QQ
Barts and The London Hospital
London
E1 2AT
Cephalon Investigational Site
Newcastle upon Tyne
NE7 7DN
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Plymouth
Devon
PL6 8BX
Novartis Investigative Site
Ayr
KA6 6DX
Middlesex
UB1 3HW
Leeds
England
Poole
Dorset
BH15 2JB
Pfizer Investigational Site
Northampton
NN1 5BD
Brighton and Sussex University Hospitals NHS Trust
Brighton
East Sussex
BN2 1ES
West Middlesex University Hospital
Isleworth
England
TW7 6AF
Basildon University Hospital
Basildon
England
SS16 5NL
School of Graduate Entry Medicine
Derby
DE22 3DT
Antrim Area Hospital
Antrim
BT41 2RL
Sandwell Hospital
West Bromwich
B71 4HJ
Receptos Study Site 966
Romford
RM7 0AG
Ballygomartin Group Practice
Belfast
Northern Ireland
BT13 3BW
London
N6A 4L6
Glasgow
G11 6NK
Abano Terme
35031
Belfast
BT47 6SB
Novartis Investigative Site
Craigavon
Northern Ireland
BT63 5QQ
Inverness
IV2 4RE
Isle of Wight
Swanage
30 5TG.
St Mary's Hospital
Paddington
London
W2 1LA
Stoker on Trent
Stoke-on-Trent
ST4 6QG
Investigational Site Number 826-007
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
United States, 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
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 Assigned

05 Jan 2010

Last Updated

17 Aug 2015