Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4879
Source ID: NCT00239538
Associated Drug: Telmisartan Combined With Hydrochlorothiazide (80/12.5 Mg)
Title: SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hypertension|Diabetes Mellitus, Type 2
Interventions: DRUG: telmisartan combined with hydrochlorothiazide (80/12.5 mg)|DRUG: valsartan combined with hydrochlorothiazide (160/12.5mg)
Outcome Measures: Primary: Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM), 10 weeks | Secondary: Changes from baseline in the last 6-hour ABPM mean (relative to dose time) pulse pressure., 10 weeks|Changes from baseline in the 24-hour ABPM mean (relative to dose time) for SBP, DBP and pulse pressure., 10 weeks|Changes from baseline in the ABPM mean (relative to clock time) for SBP, DBP, and pulse pressure during the morning, daytime and night time periods of the 24-hour dosing interval., 10 weeks|Changes from baseline in SBP and DBP load during the 24-hour dosing interval., 10 weeks|Responder rates based on the 24-hour ABPM mean (relative to dose time) blood pressures defined, 10 weeks|In-clinic trough cuff blood pressure measures at the end of both a 4-week (Visit 4) treatment period and a 10-week (Visit 6) treatment period., 4 weeks and 10 weeks|Responder rates based on the mean seated trough cuff measurements, 4 weeks and 10 weeks|Metabolic and inflammatory marker changes from baseline, up to 10 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 840
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-01
Completion Date: 2004-12
Results First Posted:
Last Update Posted: 2013-11-08
Locations: Cooper Green Hospital, Birmingham, Alabama, 35223, United States|Boehringer Ingelheim Investigational Site, Birmingham, Alabama, 35294-2041, United States|Boehringer Ingelheim Investigational Site, Huntsville, Alabama, 35801, United States|Boehringer Ingelheim Investigational Site, Mobile, Alabama, 36608, United States|Boehringer Ingelheim Investigational Site, Glendale, Arizona, 85306, United States|Boehringer Ingelheim Investigational Site, Tucson, Arizona, 85712, United States|Memorial Research Medical Clinic, Long Beach, California, 90806, United States|1200, Los Angeles, California, 90033, United States|Boehringer Ingelheim Investigational Site, Los Angeles, California, 90057, United States|8615, Nuena Park, California, 90620, United States|Boehringer Ingelheim Investigational Site, Orange, California, 92868, United States|Boehringer Ingelheim Investigational Site, Sacramento, California, 95825, United States|Boehringer Ingelheim Investigational Site, Sacramento, California, 95841, United States|595, San Francisco, California, 94132, United States|1805, Stockton, California, 95204, United States|Boehringer Ingelheim Investigational Site, Torrance, California, 90505, United States|2311, Washington, District of Columbia, 20037, United States|Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, 33308, United States|Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, 33308-4311, United States|6448, Hollywood, Florida, 33023, United States|Boehringer Ingelheim Investigational Site, Melbourne, Florida, 32901, United States|Attention: Larry I. Gilderman, D.O., Pembroke Pines, Florida, 33024, United States|Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, 33027, United States|Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, 33028, United States|Boehringer Ingelheim Investigational Site, Pinellas Park, Florida, 33781, United States|Boehringer Ingelheim Investigational Site, West Palm Beach, Florida, 33401, United States|Herron Medical Center, Ltd., Chicago, Illinois, 60610, United States|Boehringer Ingelheim Investigational Site, Chicago, Illinois, 60612, United States|Boehringer Ingelheim Investigational Site, Orland Park, Illinois, 60462, United States|Boehringer Ingelheim Investigational Site, Evansville, Indiana, 47710, United States|Boehringer Ingelheim Investigational Site, Evansville, Indiana, 47713, United States|Boehringer Ingelheim Investigational Site, Shawnee, Kansas, 66216, United States|Boehringer Ingelheim Investigational Site, Wichita, Kansas, 67212, United States|Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, 70119, United States|Boehringer Ingelheim Investigational Site, Baltimore, Maryland, 21204, United States|200, Baltimore, Maryland, 21218, United States|Boehringer Ingelheim Investigational Site, Kansas City, Missouri, 64114, United States|12401, St.Louis, Missouri, 63141, United States|Boehringer Ingelheim Investigational Site, Missoula, Montana, 59802, United States|Boehringer Ingelheim Investigational Site, Brooklyn, New York, 11203, United States|3, Buffalo, New York, 14209, United States|Comprehensive Clinical Research, Berlin, North Carolina, 08009, United States|Boehringer Ingelheim Investigational Site, Winston Salem, North Carolina, 27103, United States|Boehringer Ingelheim Investigational Site, Kettering, Ohio, 45429, United States|Boehringer Ingelheim Investigational Site, Marion, Ohio, 43302, United States|Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, 73132-4904, United States|Boehringer Ingelheim Investigational Site, Portland, Oregon, 97232, United States|Boehringer Ingelheim Investigational Site, Broomal, Pennsylvania, 19008, United States|6605, Bartlett, Tennessee, 38134, United States|108, Fayetteville, Tennessee, 37334, United States|Boehringer Ingelheim Investigational Site, Carrollton, Texas, 75006, United States|7777, Dallas, Texas, 75230, United States|Boehringer Ingelheim Investigational Site, El Paso, Texas, 79912, United States|Team Research of Texas, Harker Heights, Texas, 76548, United States|Boehringer Ingelheim Investigational Site, San Antonio, Texas, 78217, United States|Boehringer Ingelheim Investigational Site, San Antonio, Texas, 78229-4801, United States|420, Salt Lake City, Utah, 84111, United States|20901, Ettrick, Virginia, 23803, United States|Boehringer Ingelheim Investigational Site, Spokane, Washington, 99207, United States|5000, Miwaukee, Wisconsin, 53295, United States|Boehringer Ingelheim Investigational Site, BsAs, C1425AST, Argentina|Boehringer Ingelheim Investigational Site, Coronel Suárez, 7540, Argentina|Boehringer Ingelheim Investigational Site, Rosario, Sta. Fe, 2000, Argentina|Boehringer Ingelheim Investigational Site, Kippa-Ring, Queensland, 4021, Australia|Emeritus Research, Malvern, Victoria, 3144, Australia|Boehringer Ingelheim Investigational Site, Prahran, Victoria, 3181, Australia|Boehringer Ingelheim Investigational Site, Calgary, Alberta, T2N 2T9, Canada|Boehringer Ingelheim Investigational Site, Conquitlam, British Columbia, V3K 3V9, Canada|Dr. Hugh Tildesley, Vancouver, British Columbia, V6E 1M7, Canada|Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, V6Z 1Y8, Canada|Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada|Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada|Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, B3H2Y9, Canada|Boehringer Ingelheim Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|Boehringer Ingelheim Investigational Site, Kitchener, Ontario, N2H 2P2, Canada|Boehringer Ingelheim Investigational Site, London, Ontario, N6G 2M3, Canada|Boehringer Ingelheim Investigational Site, London, Ontario, N6G 2V2, Canada|Boehringer Ingelheim Investigational Site, Mississauga, Ontario, L5K 2N6, Canada|Boehringer Ingelheim Investigational Site, North York, Ontario, M3J 1N2, Canada|Boehringer Ingelheim Investigational Site, Oakville, Ontario, L6H 3P1, Canada|Boehringer Ingelheim Investigational Site, Orleans, Ontario, K1C 1S6, Canada|Boehringer Ingelheim Investigational Site, Sarnia, Ontario, N7T 4X3, Canada|LMC Thornhill, Thornhill, Ontario, L4J 1V8, Canada|Boehringer Ingelheim Investigational Site, Thunder Bay, Ontario, P7E 6E7, Canada|Boehringer Ingelheim Investigational Site, Toronto, Ontario, M4R 2G4, Canada|91 Thomas-Chapais, Boucherville, Quebec, J4B 6P3, Canada|Boehringer Ingelheim Investigational Site, Montreal, Quebec, H2W 1T7, Canada|Pavillon St. Sacrement, Sainte-Foy, Quebec, G1S 4L8, Canada|Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, S7K 3H3, Canada|Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, S7K 7H9, Canada|c/o Hemodynamics Offices, Saskatoon, Saskatchewan, S7N 0W8, Canada|Inje University Pusan Hospital, Busan, Korea, Republic of|Yeungnam University Medical Center, Daegu, 705717, Korea, Republic of|Korea University Medical Center, Seoul, 136705, Korea, Republic of|Boehringer Ingelheim Investigational Site, Col. Del Valle, CP 03100, Mexico|Boehringer Ingelheim Investigational Site, Col. Magdalena de las Salinas, C.P 07300, Mexico|Boehringer Ingelheim Investigational Site, Col. Sección 16, México, D.F., C.P. 14000, Mexico|Boehringer Ingelheim Investigational Site, Guadalajara, Jalisco, C.P 44700, Mexico|Boehringer Ingelheim Investigational Site, Zapopan, Jalisco, 45100, Mexico|Boehringer Ingelheim Investigational Site, Auckland, New Zealand|1st Floor Hagely Hostel, Christchurch, New Zealand|National Taiwan University Hospital, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT00239538

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D282 Telmisartan small molecule DB00966 Details
D296 Hydrochlorothiazide small molecule DB00999 Details
D043 Valsartan small molecule DB00177 Details