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Clinical Trial Details

Trial ID: L2982
Source ID: NCT01195662
Associated Drug: Dapagliflozin
Title: A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01195662/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Placebo matching Dapagliflozin
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants, Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured., Baseline to Week 12|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants, Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period., Baseline to Week 12 | Secondary: Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF), Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site., Baseline, Week 12|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants, Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured., Baseline to Week 12|Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF), Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site., Baseline, Week 12|Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants, Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented., Baseline, Week 12|Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue, Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events., Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event|Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue, Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (\>) less than (\<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin \<6 (\>18 females or \>20 males) g/dL; creatinine (\>=1.5\*preRX, \>=2.5 mg/dL); glucose \< 54 or (\> 350) mg/dL; albumin \<= 2 or (\> 6) g/dL; creatine kinase \>5\*ULN; albumin/creatinine ratio (\>1800 mg/G); calcium \<7.5 (\>1 and \>0.5 from PreRX) mg/dL; bicarbonate \<=13 meq/dL; potassium \<=2.5 (\>6) meq/L; magnesium \<1 (\>4) mEq/L; sodium \< 130 mEq/L (\>150 mEq/L; phosphorus (\>=5.6 mg/dL age 17-65, \>=5.1 is \>=66 years); Albumin/creatinine ratio (\>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure., Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days|Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue, Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (\>3\*ULN); ALP (\>1.5\*ULN); bilirubin (\>1.5\*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug., Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue, 12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing., Baseline, Week 12|Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue, Orthostatic hypotension was defined as a decrease from supine to standing of \> 20 mmHg in systolic BP or \>10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator., Baseline (Day 1), Week 12
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2245
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2013-02
Results First Posted: 2014-05-23
Last Update Posted: 2016-12-29
Locations: University Of Alabama At Birmingham, Birmingham, Alabama, 35294, United States|Medical Affiliated Research Center, Inc., Huntsville, Alabama, 35801, United States|Wilmax Clinical Research, Inc., Mobile, Alabama, 36608, United States|43rd Medical Associates, Phoenix, Arizona, 85051, United States|Central Phoenix Medical Center, Tempe, Arizona, 85282, United States|Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc, Tempe, Arizona, 85282, United States|Clinical Research Advantage/Desert Clinical Research, Tempe, Arizona, 85282, United States|Visions Clinical Research - Tucson, Tucson, Arizona, 85712, United States|Eclipse Clinical Research, Tucson, Arizona, 85745, United States|Aureus Research, Inc., Little Rock, Arkansas, 72211, United States|Preferred Research Partners, Inc., Little Rock, Arkansas, 72211, United States|Cmp Research, Anaheim, California, 92805, United States|Catalina Research Institute, Llc, Chino, California, 91710, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Marin Endocrine Care & Research, Inc., Greenbrae, California, 94904, United States|Del Rosario Medical Clinic, Inc., Huntington Park, California, 90255, United States|Time Clinical Research Inc., Huntington Park, California, 90255, United States|Clinica Medica San Miguel, Los Angeles, California, 90015, United States|American Institute Of Research, Los Angeles, California, 90017, United States|Randall G. Shue, D.O., Los Angeles, California, 90023, United States|Mcs Clinical Trials, Los Angeles, California, 90057, United States|National Research Inst, Los Angeles, California, 90057, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Valley Clinical Trials, Northridge, California, 91325, United States|Lucita M. Cruz,Md.,Inc., Norwalk, California, 90650, United States|Sds Clinical Trials, Orange, California, 92868, United States|Bayview Research Group, Llc, Paramount, California, 90723, United States|San Diego Managed Care Group, Poway, California, 92064, United States|Integrated Research Group, Inc., Riverside, California, 92506, United States|Quality Control Research, Inc, Sacramento, California, 95842, United States|Wetlin Research Associates, Inc., San Diego, California, 92120, United States|Crest Clinical Trials, Inc., Santa Ana, California, 92701, United States|Neurological Research Institute, Santa Monica, California, 90404, United States|Orrin M. Troum, Md And Medical Associates, Santa Monica, California, 90404, United States|Torrance Clinical Research, Torrance, California, 90505, United States|Orange County Research Center, Tustin, California, 92780, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Chase Medical Research, Llc, Waterbury, Connecticut, 06708, United States|Christiana Care Health Services, Inc, Newark, Delaware, 19713, United States|Zasa Clinical Research, Boynton Beach, Florida, 33472, United States|Bradenton Research Center, Inc., Bradenton, Florida, 34205, United States|Innovative Research Of West Florida, Inc, Clearwater, Florida, 33756, United States|Clinical Research Of South Florida, Coral Gables, Florida, 33134, United States|Avail Clinical Research, Llc, Deland, Florida, 32720, United States|International Research Associates, Llc, Hialeah, Florida, 33012, United States|Palm Springs Research Institute, Hialeah, Florida, 33012, United States|The Community Research Of South Florida, Hialeah, Florida, 33016, United States|Central Florida Internists, Kissimmee, Florida, 34741, United States|Newphase Clinical Trials, Inc., Miami Beach, Florida, 33140, United States|Ocean Blue Medical Research Center, Inc., Miami Springs, Florida, 33166, United States|Flcri Global Research, Llc, Miami, Florida, 33125, United States|Clinical Research Of Miami, Inc., Miami, Florida, 33126, United States|Pharmax Research Clinic, Inc., Miami, Florida, 33126, United States|Apf Research, Llc, Miami, Florida, 33135, United States|Community Research Foundation, Inc., Miami, Florida, 33155, United States|Baptist Diabetes Associates, Pa, Miami, Florida, 33156, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Florida Institute For Clinical Research, Llc, Orlando, Florida, 32822, United States|Michele A. Morrison Internal Medicine, Inc., Pembroke Pines, Florida, 33026, United States|Medsol Clinical Research Center, Port Charlotte, Florida, 33952, United States|Meridien Research, Tampa, Florida, 33606, United States|Perimeter Institute For Clinical Research, Atlanta, Georgia, 30338, United States|Bainbridge Medical Associates, Bainbridge, Georgia, 39819, United States|River Birch Research Alliance, Llc, Blue Ridge, Georgia, 30513, United States|In-Quest Medical Research, Llc, Duluth, Georgia, 30096, United States|Middle Georgia Drug Study Center, Llc, Perry, Georgia, 31069, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc, O?Fallon, Illinois, 62269, United States|Springfield Diabetes And Endocrine Center, Springfield, Illinois, 62704, United States|American Health Network Of Indiana Llc, Avon, Indiana, 46123, United States|Investigators Research Group, Llc, Brownsburg, Indiana, 46112, United States|American Health Network Of In Llc, Franklin, Indiana, 46131, United States|Laporte County Institute For Clinical Research, Inc., Michigan City, Indiana, 46360, United States|American Health Network Of In Llc, Muncie, Indiana, 47304, United States|Medical Development Centers, Llc, Baton Rouge, Louisiana, 70808, United States|Omega Clinical Research, Llc, Metairie, Louisiana, 70006, United States|Acadia Clinical Research, Llc, Bangor, Maine, 04401, United States|Alternative Primary Care, Silver Spring, Maryland, 20910, United States|Hci-Metromedic Walk-In Medical Office, New Bedford, Massachusetts, 02740, United States|Neurocare, Inc., Newton, Massachusetts, 02459, United States|Atlantic Clinical Trials, Llc, Watertown, Massachusetts, 02472, United States|Providence Park Clinical Research, Novi, Michigan, 48374, United States|The Center For Clinical Trials, Biloxi, Mississippi, 39531, United States|Phillips Medical Services, Pllc, Jackson, Mississippi, 39209, United States|Jefferson City Medical Group, Jefferson City, Missouri, 65109, United States|Kcumb Dybedal Clinical Research Center, Kansas City, Missouri, 64106, United States|Clin Research Advantage, Inc. James Meli, Do Family Pracice, Henderson, Nevada, 89014, United States|Office Of Ted Thorp, Md, Las Vegas, Nevada, 89102, United States|Independent Clinical Researchers@ Wolfson Medical Center, Las Vegas, Nevada, 89103, United States|Clinical Research Advantage, Inc., Las Vegas, Nevada, 89128, United States|Palm Medical Research Center, Las Vegas, Nevada, 89148, United States|Comprehensive Clinical Research, Berlin, New Jersey, 08009, United States|Premier Research, Trenton, New Jersey, 08611, United States|Medex Healthcare Research, Inc., New York, New York, 10022, United States|Digiovanna Institute For Medical Education & Research, North Massapequa, New York, 11758, United States|Southgate Medical Group, West Seneca, New York, 14224, United States|Diabetes & Endocrinology Consultants, Morehead City, North Carolina, 28557, United States|Burke Primary Care, Morganton, North Carolina, 28655, United States|Lillestol Research, Fargo, North Dakota, 58103, United States|Community Health Care, Inc., Canal Fulton, Ohio, 44614, United States|Community Research, Cincinnati, Ohio, 45227, United States|Parsons Avenue Medical Clinical, Columbus, Ohio, 43207, United States|Clinical Research Source, Inc, Perrysburg, Ohio, 43551, United States|Sooner Clinical Research, Oklahoma City, Oklahoma, 73112, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73099, United States|Willamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Southeastern Pa Medical Institute, Broomall, Pennsylvania, 19008, United States|Abington Memorial Hos/Feasterville Family Health Care Center, Feasterville, Pennsylvania, 19053, United States|The Clinical Trial Center, Llc, Jenkintown, Pennsylvania, 19046, United States|Arcuri Clinical Research Llc, Philadelphia, Pennsylvania, 19142, United States|Philadelphia Health Associates - Adult Medicine, Philadelphia, Pennsylvania, 19146, United States|Research Across America, Reading, Pennsylvania, 19606, United States|Pish Medical Associates, Uniontown, Pennsylvania, 15401, United States|Greater Providence Clinical Research, Llc, Warwick, Rhode Island, 02888, United States|Medical Research South, Charleston, South Carolina, 29407, United States|Southeastern Research Associates, Inc., Greenville, South Carolina, 29605, United States|North Myrtle Beach Family Practice, North Myrtle Beach, South Carolina, 29582, United States|Pawleys Pediatrics And Adult Medicine, Pawleys Island, South Carolina, 29585, United States|Hillcrest Clinical Reseach, Llc, Simpsonville, South Carolina, 29681, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Southwind Medical Specialists, Memphis, Tennessee, 38125, United States|Tn Medical Research, Spring Hill, Tennessee, 37174, United States|Arlington Family Research Center, Inc., Arlington, Texas, 76012, United States|3rd Coast Research Associates, Corpus Christi, Texas, 78414, United States|Krk Medical Research, Dallas, Texas, 75230, United States|Research Institute Of Dallas, Dallas, Texas, 75231, United States|Internal Medicine Clinical Reaseach, Dallas, Texas, 75235, United States|Renaissance Clinical Research And Hypertension Pllc, Dallas, Texas, 75235, United States|Sergio F. Rovner, M.D., El Paso, Texas, 79925, United States|Pioneer Research Solutions, Inc., Houston, Texas, 77008, United States|Village Family Practice, Houston, Texas, 77024, United States|Dependable Clinical Research, Llc, Houston, Texas, 77074, United States|Southwest Clinical Trials, Houston, Texas, 77074, United States|Bellaire Medical Care Group, Houston, Texas, 77081, United States|Excel Clinical Research, Llc, Houston, Texas, 77081, United States|Hill Country Medical Associates, New Braunfels, Texas, 78130, United States|North Hills Medical Research, Inc., North Richland Hills, Texas, 76180, United States|Med-Olam Clinical Research, Pasadena, Texas, 77504, United States|Lisa E. Medwedeff, Md, Pa, Plano, Texas, 75024, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|Abbott Clinical Research Group, Inc., San Antonio, Texas, 78224, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|Innovative Clinical Trials, San Antonio, Texas, 78229, United States|Breco Research, Ltd, Sugarland, Texas, 77479, United States|Exodus Healthcare Network, Magna, Utah, 84044, United States|Wasatch Endocrinology And Diabetes Specialists, Salt Lake City, Utah, 84102, United States|Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States|Alexandria Health Care Center, Alexandria, Virginia, 22314, United States|Millennium Clinical Trials Llc, Arlington, Virginia, 22203, United States|Burke Internal Medicine And Research, Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Hampton Roads Center For Clinical Research, Inc., Suffolk, Virginia, 23435, United States|Larry D. Stonesifer, Md, Federal Way, Washington, 98003, United States|Sound Medical Research, Port Orchard, Washington, 98366, United States|Clinical Investigation Specialists, Inc., Kenosha, Wisconsin, 53142, United States|Local Institution, Camperdown, New South Wales, 2050, Australia|Local Institution, Heidelberg, Victoria, 3081, Australia|Local Institution, Nedlands, Western Australia, 6009, Australia|Local Institution, Kelowona, British Columbia, V1Y 3G8, Canada|Local Institution, Victoria, British Columbia, V8V 3N7, Canada|Local Institution, Monction, New Brunswick, E1G 1A7, Canada|Local Institution, Brampton, Ontario, L6T 3J1, Canada|Local Institution, Granby, Quebec, J2G 8Z9, Canada|Local Institution, Montreal, Quebec, H2R 1V6, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Armenia, Quindio, 0000, Colombia|Local Institution, Bucaramanga, Santander, 0000, Colombia|Local Institution, Barranquilla, 0000, Colombia|Local Institution, Barranquilla, Colombia|Local Institution, Bogota, 0000, Colombia|Local Institution, Beroun, 266 01, Czech Republic|Local Institution, Cheb, 350 02, Czech Republic|Local Institution, Havirov, 736 01, Czech Republic|Local Institution, Krnov, 794 01, Czech Republic|Local Institution, Liberec, 460 01, Czech Republic|Local Institution, Ostrava, 702 00, Czech Republic|Local Institution, Prague 1, 116 94, Czech Republic|Local Institution, Praha 4, 149 00, Czech Republic|Local Institution, Copenhagen, DK 2400, Denmark|Local Institution, Frederiksberg, 2000, Denmark|Local Institution, Gentofte, 2820, Denmark|Local Institution, Slagelse, 4200, Denmark|Local Institution, Helsinki, 09200, Finland|Local Institution, Kerava, 04200, Finland|Local Institution, Kokkola, 67100, Finland|Local Institution, Oulu, 90100, Finland|Local Institution, Aschaffenburg, Bavaria, 63739, Germany|Local Institution, Augsburg, Bavaria, 86150, Germany|Local Institution, Duisburg, Nordrhein-Westfalen, 47051, Germany|Local Institution, Bad Kreuznach, 55545, Germany|Local Institution, Berlin, 10787, Germany|Local Institution, Dortmund, 44137, Germany|Local Institution, Dresden, 01307, Germany|Local Institution, Karlsruhe, 76199, Germany|Local Institution, Kothen, 06366, Germany|Local Institution, Kronshagen, 24119, Germany|Local Institution, Langenfeld, 40764, Germany|Local Institution, Lueneburg, 21339, Germany|Local Institution, Magdeburg, 39112, Germany|Local Institution, Mainz, 55116, Germany|Local Institution, Mannheim, 68161, Germany|Local Institution, Saarbruecken, 66121, Germany|Local Institution, Wuestensachsen, 36115, Germany|Local Institution, Gyongyos, Heves, 3200, Hungary|Local Institution, Budapest, 1134, Hungary|Local Institution, Budapest, H-1171, Hungary|Local Institution, Eger, 3300, Hungary|Local Institution, Kisvarda, 4600, Hungary|Local Institution, Miskolc, 3530, Hungary|Local Institution, Nyiregyhaza, 4400, Hungary|Local Institution, Satoraljaujhely, 3980, Hungary|Local Institution, Sopron, 9400, Hungary|Local Institution, Szeged, 6720, Hungary|Local Institution, Szekszard, H-7100, Hungary|Local Institution, Hyderabad, Andhra Pradesh, 5000 18, India|Local Institution, Bangalore, Karnataka, 560 043, India|Local Institution, Bangalore, Karnataka, 560043, India|Local Institution, Bangalore, Karnataka, 560092, India|Local Institution, Mangalore, Karnataka, 575001, India|Local Institution, Belgaum, Karnatka, 590010, India|Local Institution, Indore, Madhya Pradesh, 452010, India|Local Institution, Nagpur, Maharashtra, 440010, India|Local Institution, Nagpur, Maharashtra, 440012, India|Local Institution, Nagpur, Maharashtra, 440033, India|Local Institution, Delhi, New Delhi, 110007, India|Local Institution, Jaipur, Rajasthan, 202023, India|Local Institution, Chennai, Tamil Nadu, 600013, India|Local Institution, Coimbatore, Tamil Nadu, 641 018, India|Local Institution, Madurai, Tamilnadu, 625020, India|Local Institution, Chennai Tamilnadu, 6000081, India|Local Institution, Hyderabad, 500063, India|Local Institution, Nagpur, 440012, India|Local Institution, Trivandrum, 695011, India|Local Institution, Dublin 15, Dublin, Ireland|Local Institution, Galway, Ireland|Local Institution, Torreon, Coahuila, 27000, Mexico|Local Institution, Mexico City, Distrito Federal, 03300, Mexico|Local Institution, Mexico City, Distrito Federal, 07760, Mexico|Local Institution, Guadalajara, Jalisco, 44100, Mexico|Local Institution, Guadalajara, Jalisco, 44130, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Cuautla, Morelos, 62744, Mexico|Local Institution, Monterrey, Nuevo Leon, 64000, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Culiacan, Sinaloa, 80020, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Chihuahua, 31217, Mexico|Local Institution, Del. Benito Juarez, 03100, Mexico|Local Institution, Delegacion Tlalpan, 14000, Mexico|Local Institution, Distrito Federal, 07020, Mexico|Local Institution, San Luis Potosi, 78200, Mexico|Local Institution, Bialystok, 15-404, Poland|Local Institution, Bialystok, 15-879, Poland|Local Institution, Chrzanow, 32-500, Poland|Local Institution, Elblag, 82-300, Poland|Local Institution, Gdansk, 80-847, Poland|Local Institution, Gdynia, 81-384, Poland|Local Institution, Kamieniec Zabkowicki, 57-230, Poland|Local Institution, Katowice, 40-748, Poland|Local Institution, Kielce, 25-364, Poland|Local Institution, Krakow, 30-015, Poland|Local Institution, Krakow, 31-159, Poland|Local Institution, Lodz, 90-242, Poland|Local Institution, Lodz, 92-525, Poland|Local Institution, Lublin, 20-044, Poland|Local Institution, Ostroda, 14-100, Poland|Local Institution, Poznan, 61-251, Poland|Local Institution, Warsaw, 02-097, Poland|Local Institution, Warsaw, 02-507, Poland|Local Institution, Warszawa, 01-192, Poland|Local Institution, Warszawa, 01-337, Poland|Local Institution, Warszawa, 01-868, Poland|Local Institution, Wroclaw, 50-088, Poland|Local Institution, Wroclaw, 50-349, Poland|Local Institution, Zabrze, 41-800, Poland|Local Institution, Fajard, 00738, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico|Local Institution, Oradea, Bihor, 410169, Romania|Local Institution, Oradea, Jud. Bihor, 410469, Romania|Local Institution, Timisoara, Jud. Timis, 300125, Romania|Local Institution, Targu Mures, Mures, 540098, Romania|Local Institution, Targu Mures, Mures, 540142, Romania|Local Institution, Ploiesti, Prahova, 100163, Romania|Local Institution, Ploiesti, Prahova, 100342, Romania|Local Institution, Timisoara, Timis, 300456, Romania|Local Institution, Bucuresti, 010507, Romania|Local Institution, Bucuresti, 010719, Romania|Local Institution, Bucuresti, 020475, Romania|Local Institution, Bucuresti, 020725, Romania|Local Institution, Cluj-Napoca, 400006, Romania|Local Institution, Satu Mare, 440055, Romania|Local Institution, Sibiu, 550245, Romania|Local Institution, Sibiu, 550371, Romania|Local Institution, Irvine, Ayrshire, KA11 1JU, United Kingdom|Local Institution, Ely, Cambridgeshire, CB7 5JD, United Kingdom|Local Institution, Birmingham, West Midlands, B9 5SS, United Kingdom|Local Institution, Bath, Wiltshire, BA2 3HT, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01195662