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Clinical Trial Details

Trial ID: L5592
Source ID: NCT00744237
Associated Drug: Nebivolol
Title: Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00744237/results
Conditions: Hypertension|Type 2 Diabetes Mellitus
Interventions: DRUG: Nebivolol|DRUG: Metoprolol ER|DRUG: HCTZ
Outcome Measures: Primary: Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26, Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward., visit 5(week 0) and visit 14(week 26) | Secondary: Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5, [visit 5(week 0) and visit 14(week 26)]
Sponsor/Collaborators: Sponsor: Forest Laboratories
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 231
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date:
Results First Posted: 2011-07-29
Last Update Posted: 2011-07-29
Locations: Forest Investigative Site 15, Athens, Alabama, 35611, United States|Forest Investigative Site 16, Huntsville, Alabama, 35801, United States|Forest Investigative Site 35, Bell Gardens, California, 90201, United States|Forest Investigative Site, Buena Park, California, 90620, United States|Forest Investigative Site 54, Chino, California, 91710, United States|Forest Investigative Site 40, Fremont, California, 94538, United States|Forest Investigative Site, Palm Springs, California, 92262, United States|Forest Investigative Site, Pomona, California, 91767, United States|Forest Investigative Site 55, Sacramento, California, 95821, United States|Forest Investigative Site 11, San Diego, California, 92128, United States|Forest Investigative Site, Santa Monica, California, 90404, United States|Forest Investigative Site, Spring Valley, California, 91978, United States|Forest Investigative Site 49, Tustin, California, 92780, United States|Forest Investigative Site 47, Walnut Creek, California, 94598, United States|Forest Investigative Site 61, Golden, Colorado, 80401, United States|Forest Investigative Site, Wheat Ridge, Colorado, 80033, United States|Forest Investigative Site 3, Daytona Beach, Florida, 32117, United States|Forest Investigative Site 33, DeLand, Florida, 32720, United States|Forest Investigative Site 36, Hollywood, Florida, 33023, United States|Forest Investigative Site 62, Miami, Florida, 33135, United States|Forest Investigative Site 080, Miami, Florida, 33169, United States|Forest Investigative Site 59, Miami, Florida, 33183, United States|Forest Investigative Site 32, Pembroke Pines, Florida, 33024, United States|Forest Investigative Site 081, Pembroke Pines, Florida, 33028, United States|Forest Investigative Site 2, Tamarac, Florida, 33321, United States|Forest Investigative Site, Tampa, Florida, 33612, United States|Forest Investigative Site 19, West Palm Beach, Florida, 33401, United States|Forest Investigative Site 44, Atlanta, Georgia, 30312, United States|Forest Investigative Site 5, Augusta, Georgia, 30904, United States|Forest Investigative Site 56, Honolulu, Hawaii, 96814, United States|Forest Investigative Site 57, Meridian, Idaho, 83646, United States|Forest Investigative Site 39, Chicago, Illinois, 60607, United States|Forest Investigative Site 37, Wichita, Kansas, 67203, United States|Forest Investigative Site, Baltimore, Maryland, 21204, United States|Forest Investigative Site 20, Baltimore, Maryland, 21209, United States|Forest Investigative Site 50, Oxon Hill, Maryland, 20745, United States|Forest Investigative Site 21, St. Clair Shores, Michigan, 48081, United States|Forest Investigative Site, Kansas City, Missouri, 64111, United States|Forest Investigative Site, St. Louis, Missouri, 63110, United States|Forest Investigative Site, New Hyde Park, New York, 11042, United States|Forest Investigative Site, New York, New York, 10032, United States|Forest Investigative Site 7, Charlotte, North Carolina, 28211, United States|Forest Investigative Site 45, Charlotte, North Carolina, 28262, United States|Forest Investigative Site 24, Morehead City, North Carolina, 28557, United States|Forest Investigative Site 26, Salisbury, North Carolina, 28144, United States|Forest Investigative Site 18, Wilmington, North Carolina, 28401, United States|Forest Investigative Site 51, Centerville, Ohio, 45459, United States|Forest Investigative Site 48, Cincinnati, Ohio, 45242, United States|Forest Investigative Site 12, Wadsworth, Ohio, 44281, United States|Forest Investigative Site 17, Charleston, South Carolina, 29407, United States|Forest Investigative Site 46, Columbia, South Carolina, 29201, United States|Forest Investigative Site, North Charleston, South Carolina, 29406, United States|Forest Investigative Site, Simpsonville, South Carolina, 29681, United States|Forest Investigative Site 4, Sioux Falls, South Dakota, 57104, United States|Forest Investigative Site 10, New Tazewell, Tennessee, 37825, United States|Forest Investigative Site 52, Corpus Christi, Texas, 78404, United States|Forest Investigative Site 28, Dallas, Texas, 75390, United States|Forest Investigative Site 38, Hurst, Texas, 76054, United States|Forest Investigative Site 34, Salt Lake City, Utah, 84102, United States|Forest Investigative Site, St. George, Utah, 84790, United States|Forest Investigative Site, Norfolk, Virginia, 23502, United States|Forest Investigative Site 31, Virginia Beach, Virginia, 23452, United States|Forest Investigative Site 41, Ponce, 00717, Puerto Rico|Forest Investigative Site 60, Salinas, 00751, Puerto Rico|Forest Investigative Site 29, Santurce, 00909, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00744237

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D431 Nebivolol small molecule DB04861 Details
D296 Hydrochlorothiazide small molecule DB00999 Details