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Clinical Trial Details

Trial ID: L4387
Source ID: NCT00762736
Associated Drug: Pioglitazone And Azilsartan
Title: Efficacy and Safety of Pioglitazone and Azilsartan in Treating Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Pioglitazone and azilsartan|DRUG: Pioglitazone and azilsartan|DRUG: Pioglitazone|DRUG: Pioglitazone and azilsartan|DRUG: Pioglitazone and azilsartan|DRUG: Pioglitazone
Outcome Measures: Primary: Change from Baseline in glycosylated hemoglobin., Week 24 or Final Visit | Secondary: Change from Baseline in glycosylated hemoglobin., Weeks 12, 16, 20, and 24 or Final Visit|Change from Baseline in fasting plasma glucose., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in total cholesterol., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in high-density lipoprotein., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in low-density lipoprotein., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in triglycerides., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in body weight., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in systolic and diastolic blood pressure., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in incidence of edema (peripheral)., Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit|Change from Baseline in microalbuminuria excretion., Week 24 or Final Visit|Change from Baseline in high-sensitivity C-reactive protein., Weeks 12 and 24 or Final Visit|Change from Baseline in matrix metalloproteinase-9., Weeks 12 and 24 or Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 704
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2004-07
Completion Date: 2005-10
Results First Posted:
Last Update Posted: 2012-02-28
Locations: Birmingham,, Alabama, United States|Huntsville, Alabama, United States|Sierra Vista, Arizona, United States|Sun City, Arizona, United States|Tucson, Arizona, United States|Burbank, California, United States|Escondido, California, United States|Irvine, California, United States|La Jolla, California, United States|National City, California, United States|Riverside, California, United States|Sacramento, California, United States|San Diego, California, United States|Spring Valley, California, United States|Coral Gables, Florida, United States|Deland, Florida, United States|Hollywood, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Opalocka, Florida, United States|Pembroke Pines, Florida, United States|Sarasota, Florida, United States|Vero Beach, Florida, United States|Atlanta, Georgia, United States|Augusta, Georgia, United States|Warner Robins, Georgia, United States|Honolulu, Hawaii, United States|Lihue, Hawaii, United States|Chicago, Illinois, United States|Dyersburg, Indiana, United States|Overland Park, Kansas, United States|Wichita, Kansas, United States|New Orleans, Louisiana, United States|Shreveport, Louisiana, United States|Salisbury, Massachusetts, United States|Cadillac, Michigan, United States|Detroit, Michigan, United States|Livonia, Michigan, United States|Kansas City, Missouri, United States|St. Louis, Missouri, United States|Las Vegas, Nevada, United States|North Las Vegas, Nevada, United States|Berlin, New Jersey, United States|Blackwood, New Jersey, United States|Trenton, New Jersey, United States|Albany, New York, United States|Kingston, New York, United States|Charlotte, North Carolina, United States|Marion, Ohio, United States|Clinton, Oklahoma, United States|Oklahoma City, Oklahoma, United States|Allentown, Pennsylvania, United States|Altoona, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Scotland,, Pennsylvania, United States|Woonsocket, Rhode Island, United States|Greer, South Carolina, United States|Arlington, Texas, United States|Dallas, Texas, United States|Fort Worth, Texas, United States|Midland,, Texas, United States|North Richard Hills, Texas, United States|San Antonio, Texas, United States|Renton, Washington, United States|Buenos Aires, Argentina|Cordoba, Argentina|Rosario-Santa Fe, Argentina|Santa Fe, Argentina|Ushuaia - Tierre del Fuego, Argentina|Santiago, Chile|Aguascalientes, Mexico|Cuernavaca, Mexico|Durango, Mexico|Guadalajara, Mexico|Mexico City, Mexico|Pueblo, Mexico|Ica, Peru|Lima, Peru
URL: https://clinicaltrials.gov/show/NCT00762736