| Outcome Measures: |
Primary: Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure, Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM)., Baseline, 6 Weeks | Secondary: Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure, Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate., Baseline, 6 Weeks|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate, Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate., Baseline, 6 Weeks|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures, Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate., Baseline, 6 Weeks|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP), Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate., Baseline, 6 Weeks|Change From Baseline in Hemoglobin A1c (HbA1c), LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate., Baseline, 6 Weeks|Population Pharmacokinetics: Apparent Clearance of LY2409021, Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups., Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021, Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups., Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.
|
| Locations: |
Advanced Clinical Research Institute, Anaheim, California, 92801, United States|National Research Institute, Los Angeles, California, 90057, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|Orange County Research Center, Tustin, California, 92780, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Berma Research, Fort Lauderdale, Florida, 33316, United States|East Coast Clinical Research, Jacksonville, Florida, 32204, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, 46260, United States|L-Marc Research Center, Louisville, Kentucky, 40213, United States|Maine Research Associates, Auburn, Maine, 04210, United States|Alzohaili Medical Consultants, Dearborn, Michigan, 48124, United States|Premier Research, Trenton, New Jersey, 08611, United States|Manhattan Medical Research, New York, New York, 10016, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Holesov, 76901, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Krnov, 79401, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pardubice, 53002, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Prague, 14059, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Coatzacoalcos, 96400, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Guadalajara, 44130, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Monterrey, 64460, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Monterrey, 64620, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gdansk, 80-546, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lodz, 90-242, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lublin, 20-538, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Poznan, 61-853, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Szczecin, 70-506, Poland|Manati Center for Clinical Research Inc, Manati, 00674, Puerto Rico|Consultorio Medico, San Juan, 00921, Puerto Rico
|