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Clinical Trial Details

Trial ID: L4286
Source ID: NCT00461058
Associated Drug: Actos
Title: A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Actos|DRUG: aleglitazar
Outcome Measures: Primary: Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period., 26 week | Secondary: Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters., 26 week|Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile., 26 week
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-05
Completion Date: 2007-12
Results First Posted:
Last Update Posted: 2016-08-05
Locations: Jonesboro, Arkansas, 72401, United States|Carmichael, California, 95608, United States|Loma Linda, California, 92354, United States|Long Beach, California, 90822, United States|Jacksonville, Florida, 32216, United States|Slidell, Louisiana, 70458, United States|Minneapolis, Minnesota, 55455, United States|Cleveland, Ohio, 44195, United States|Oklahoma City, Oklahoma, 73112, United States|Tulsa, Oklahoma, 74104, United States|Ashkelon, 78278, Israel|Haifa, 31096, Israel|Kfar Saba, 44281, Israel|Culiacan, SIN80020, Mexico|Guadalajara, JAL44340, Mexico|Metepec, EMEX52140, Mexico|Mexico City, 11650, Mexico|Mexico City, DF7060, Mexico|Monterrey, 64000, Mexico|Pachuca, 42000, Mexico|San Luis Potosi, SLP78250, Mexico|Arad, 310037, Romania|Bacau, 600114, Romania|Baia Mare, 430123, Romania|Bucuresti, 010242, Romania|Bucuresti, 20475, Romania|Bucuresti, 50452, Romania|Oradea, 410169, Romania|Ploiesti, 100097, Romania|Targoviste, 130083, Romania|Moscow, 123436, Russian Federation|Moscow, 125101, Russian Federation|Moscow, 127018, Russian Federation|Moscow, 127299, Russian Federation|Saratov, 410028, Russian Federation|St Petersburg, 191025, Russian Federation|St Petersburg, 198205, Russian Federation|St Petersburg, 199106, Russian Federation|Yaroslavl, 150062, Russian Federation|Donetsk, 83003, Ukraine|Donetsk, 83114, Ukraine|Kharkov, 61178, Ukraine|Kiev, 02091, Ukraine|Kiev, 1151, Ukraine|Kiev, 2091, Ukraine
URL: https://clinicaltrials.gov/show/NCT00461058