Clinical trial NCT01715818: A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
Official title: A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease, Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 1999
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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)
timeFrame: 5 years
Secondary outcomes:
measure: 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)
timeFrame: 5 years
measure: 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)
timeFrame: 5 years
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
state: Alabama
city: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Cudahy
country: United States
state: California
city: Encino
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state: California
city: Fresno
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city: Hawaiian Gardens
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state: California
city: Huntington Beach
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city: Los Gatos
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state: California
city: North Hollywood
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city: Mosonmagyarovar
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city: Szekesfehervar
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city: Szolnok
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city: Zalaegerszeg
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state: Campania
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city: Roma
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state: Lazio
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state: Lombardia
city: Milano
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city: Pavia
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state: Lombardia
city: Pesaro
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state: Sicilia
city: Palermo
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state: Sicilia
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state: Toscana
city: Tochigi
country: Japan
city: Busan
country: Korea, Republic of
city: Busan
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city: Daejeon
country: Korea, Republic of
city: Gwangju
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city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
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city: Gyeonggi-do
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city: Gyeonggi-Do
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city: Gyeonggi-do
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city: Seoul
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city: Seoul
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city: Seoul
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city: Suwon-si,
country: Korea, Republic of
city: Wonju
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city: Aguascalientes
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city: Mexico
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city: Monterrey
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city: Xalapa
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city: Bialystok
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city: Gdynia
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city: Gdynia
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city: Katowice
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city: Katowice
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city: Krakow
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city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
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city: Lodz
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city: Lublin
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city: Lublin
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city: Nowy Sacz
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city: Opole
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city: Rzeszow
country: Poland
city: Warsawa
country: Poland
city: Wroclaw
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city: Baia Mare
country: Romania
city: Bucharest
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city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Craiova
country: Romania
city: Oradea
country: Romania
city: Ploiesti
country: Romania
city: Targu-Mures
country: Romania
city: Kemerovo
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Pretoria-West
country: South Africa
city: Pretoria
country: South Africa
city: San Juan de Alicante
country: Spain
state: Alicante
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Lleida
country: Spain
state: Lerida
city: Málaga
country: Spain
state: Malaga
city: Seville
country: Spain
state: Sevilla
city: Alzira
country: Spain
state: Valencia
city: Albacete
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Huelva
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Malaga
country: Spain
city: Tarragona
country: Spain
city: Valencia
country: Spain
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chorley
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Inverness
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Mortimer
country: United Kingdom
city: Reading
country: United Kingdom
city: Soham, Ely
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: