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Clinical Trial Details

Trial ID: L5472
Source ID: NCT00879970
Associated Drug: Pioglitazone
Title: Thiazolidinedione Intervention With Vitamin D Evaluation
Acronym: TIDE
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00879970/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: pioglitazone|DRUG: rosiglitazone|DRUG: placebo|DIETARY_SUPPLEMENT: Vitamin D|DIETARY_SUPPLEMENT: Placebo
Outcome Measures: Primary: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD), An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function\[s\] due to disturbance in the blood supply to the brain not leading to death)., From Randomization at Visit 3 up to the Final Visit (average of 162 days)|Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D, An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery., From Randomization at Visit 3 to Final Visit (up to 162 days) | Secondary: Number of Participants With Any Revascularization, Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Need for Hospitalization for Any Reason, Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina, CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Composite Microvascular Outcome, The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a \>=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy, Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a \>=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia), Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose \<=36 mg/deciliter (2.0 millimole per liter \[mmol/L\]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Clinical Proteinuria, Clinical proteinuria is defined as a laboratory detection of urinary protein excretion \> 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio \>=300 milligrams/g; timed urine collection for albumin excretion \>=200 µg/minute or \>=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With a Fracture, Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests, Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. "Liver function test abnormal" and "hepatic enzyme increased" were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit, CD is equivalent to a difference of \>=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit)., From Randomization at Visit 3 to Final Visit (up to 162 days)|Number of Participants With Erectile Dysfunction, Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction., From Randomization at Visit 3 to Final Visit (up to 162 days)|Mean Score on Euro-QoL (EQ)-5D, Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from "0" to "1", whereby a score of "1" represents the best health state imaginable and "0" represents a health state equivalent to being dead. Negative states are those worse than being dead., From Randomization at Visit 3 to Final Visit (up to 162 days)|Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF), CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal., From Randomization at Visit 3 to Final Visit (up to 162 days)
Sponsor/Collaborators: Sponsor: GlaxoSmithKline | Collaborators: Population Health Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1332
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-05
Completion Date: 2010-11
Results First Posted: 2011-12-13
Last Update Posted: 2017-04-18
Locations: GSK Investigational Site, Long Beach, California, 90822, United States|GSK Investigational Site, Los Angeles, California, 90033, United States|GSK Investigational Site, Northridge, California, 91324, United States|GSK Investigational Site, San Diego, California, 92109, United States|GSK Investigational Site, Decatur, Georgia, 30033, United States|GSK Investigational Site, Tucker, Georgia, 30084, United States|GSK Investigational Site, Pocatella, Idaho, 83209, United States|GSK Investigational Site, Pocatello, Idaho, 83201, United States|GSK Investigational Site, New Orleans, Louisiana, 70112, United States|GSK Investigational Site, Haverhill, Massachusetts, 1830, United States|GSK Investigational Site, Minneapolis, Minnesota, 55454, United States|GSK Investigational Site, St. Louis, Missouri, 63106, United States|GSK Investigational Site, Kalispell, Montana, 59901, United States|GSK Investigational Site, Westfield, New York, 14787, United States|GSK Investigational Site, Durham, North Carolina, 27710, United States|GSK Investigational Site, Cleveland, Ohio, 44195, United States|GSK Investigational Site, Portland, Oregon, 97216, United States|GSK Investigational Site, Portland, Oregon, 97239, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, Memphis, Tennessee, 38104, United States|GSK Investigational Site, Dallas, Texas, 75246, United States|GSK Investigational Site, Houston, Texas, 77030, United States|GSK Investigational Site, Temple, Texas, 76508, United States|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, 1090, Argentina|GSK Investigational Site, Coronel Suarez, Buenos Aires, Argentina|GSK Investigational Site, Mar del Plata, Buenos Aires, 7600, Argentina|GSK Investigational Site, San Nicolas, Buenos Aires, B2900DMH, Argentina|GSK Investigational Site, Buenos Aires, 1405, Argentina|GSK Investigational Site, Salta, 4400, Argentina|GSK Investigational Site, San Miguel de Tucuman, 4000, Argentina|GSK Investigational Site, Zárate, B2800DGH, Argentina|GSK Investigational Site, Calgary, Alberta, T2T 5C7, Canada|GSK Investigational Site, Calgary, Alberta, T3S OM3, Canada|GSK Investigational Site, Edmonton, Alberta, T5A 4L8, Canada|GSK Investigational Site, Surrey, British Columbia, V3R 3P1, Canada|GSK Investigational Site, Vancouver, British Columbia, V6H 3X8, Canada|GSK Investigational Site, Winnipeg, Manitoba, R2H 0R8, Canada|GSK Investigational Site, Winnipeg, Manitoba, R2V 4W3, Canada|GSK Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|GSK Investigational Site, Saint John's, Newfoundland and Labrador, A1B 3V6, Canada|GSK Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|GSK Investigational Site, Barrie, Ontario, L4M 7G1, Canada|GSK Investigational Site, Brampton, Ontario, L6Z 4N5, Canada|GSK Investigational Site, Cambridge, Ontario, N1R 7L6, Canada|GSK Investigational Site, Hamilton., Ontario, L8N 3X5, Canada|GSK Investigational Site, Hamilton, Ontario, L8L 2X2, Canada|GSK Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|GSK Investigational Site, London, Ontario, N6A 4V2, Canada|GSK Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|GSK Investigational Site, Ohsweken, Ontario, N0A 1M0, Canada|GSK Investigational Site, Oshawa, Ontario, L1J 2K1, Canada|GSK Investigational Site, Ottawa, Ontario, K1C 1S6, Canada|GSK Investigational Site, Ottawa, Ontario, K1H 1A2, Canada|GSK Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|GSK Investigational Site, Toronto, Ontario, M4R 2G4, Canada|GSK Investigational Site, Toronto, Ontario, M5C 2T2, Canada|GSK Investigational Site, Toronto, Ontario, M9L 1W9, Canada|GSK Investigational Site, Laval, Quebec, H7T 2P5, Canada|GSK Investigational Site, Montreal, Quebec, H2W 1R7, Canada|GSK Investigational Site, Quebec City, Quebec, G1J 1Z6, Canada|GSK Investigational Site, Quebec City, Quebec, G1L 3L5, Canada|GSK Investigational Site, Quebec City, Quebec, G1V 4G5, Canada|GSK Investigational Site, Rimouski, Quebec, G5L 5T1, Canada|GSK Investigational Site, Saint-Georges, Quebec, G5Y 4T8, Canada|GSK Investigational Site, Sainte-Foy, Quebec, G1V 4G2, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 5N4, Canada|GSK Investigational Site, Temuco, Región De La Araucania, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, 8330024, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, 8331143, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, Chile|GSK Investigational Site, Osorno, Chile|GSK Investigational Site, Valdivia, Chile|GSK Investigational Site, Victoria, Chile|GSK Investigational Site, Armenia, Colombia|GSK Investigational Site, Barrangquilla, Colombia|GSK Investigational Site, Barranquilla, Colombia|GSK Investigational Site, Bogotac, 83012, Colombia|GSK Investigational Site, Bogota, Colombia|GSK Investigational Site, Cali, Colombia|GSK Investigational Site, Cartagena, 71 31-315, Colombia|GSK Investigational Site, Cartagena, Colombia|GSK Investigational Site, Espinal, Colombia|GSK Investigational Site, Floridablanca, Colombia|GSK Investigational Site, Manizales, Colombia|GSK Investigational Site, Medellín, Colombia|GSK Investigational Site, Pereira, Colombia|GSK Investigational Site, Havirov, 736 01, Czech Republic|GSK Investigational Site, Jihlava, 586 01, Czech Republic|GSK Investigational Site, Mestec Kralove, 289 03, Czech Republic|GSK Investigational Site, Ostrava, 70030, Czech Republic|GSK Investigational Site, Prague, 181 00, Czech Republic|GSK Investigational Site, Praha 4, 140 21, Czech Republic|GSK Investigational Site, Praha 5, 150 00, Czech Republic|GSK Investigational Site, Praha 5, 158 00, Czech Republic|GSK Investigational Site, Praha 6, 160 00, Czech Republic|GSK Investigational Site, Praha, 102 00, Czech Republic|GSK Investigational Site, Pribram 8, 261 01, Czech Republic|GSK Investigational Site, Rakovnik, 269 01, Czech Republic|GSK Investigational Site, Uherske Hradiste, 68601, Czech Republic|GSK Investigational Site, Aarhus-N, 8200, Denmark|GSK Investigational Site, Frederiksberg, 2000, Denmark|GSK Investigational Site, Glostrup, 2600, Denmark|GSK Investigational Site, Hellerup, 2900, Denmark|GSK Investigational Site, Herlev, DK-2730, Denmark|GSK Investigational Site, Koebenhavn, 2300, Denmark|GSK Investigational Site, København NV, 2400, Denmark|GSK Investigational Site, Odense C, 5000, Denmark|GSK Investigational Site, Viborg, 8800, Denmark|GSK Investigational Site, Helsinski, 00260, Finland|GSK Investigational Site, Kuopio, 70210, Finland|GSK Investigational Site, Oulu, 90100, Finland|GSK Investigational Site, Deggingen, Baden-Wuerttemberg, 73326, Germany|GSK Investigational Site, Villingen-Schwenningen, Baden-Wuerttemberg, 78048, Germany|GSK Investigational Site, Wangen, Baden-Wuerttemberg, 88239, Germany|GSK Investigational Site, Weinheim, Baden-Wuerttemberg, 69469, Germany|GSK Investigational Site, Augsburg, Bayern, 86150, Germany|GSK Investigational Site, Gars am Inn, Bayern, 83536, Germany|GSK Investigational Site, Haag, Bayern, 83527, Germany|GSK Investigational Site, Kuenzing, Bayern, 94550, Germany|GSK Investigational Site, Muenchen, Bayern, 80339, Germany|GSK Investigational Site, Muenchen, Bayern, 80809, Germany|GSK Investigational Site, Vilshofen, Bayern, 94474, Germany|GSK Investigational Site, Wallerfing, Bayern, 94574, Germany|GSK Investigational Site, Angermuende, Brandenburg, 16278, Germany|GSK Investigational Site, Elsterwerda, Brandenburg, 04910, Germany|GSK Investigational Site, Potsdam, Brandenburg, 14469, Germany|GSK Investigational Site, Grossalmerode, Hessen, 37247, Germany|GSK Investigational Site, Kelkheim, Hessen, 65779, Germany|GSK Investigational Site, Winsen/Lohe, Niedersachsen, 21423, Germany|GSK Investigational Site, Bad Oeynhausen, Nordrhein-Westfalen, 32545, Germany|GSK Investigational Site, Bergkamen, Nordrhein-Westfalen, 59192, Germany|GSK Investigational Site, Dorsten, Nordrhein-Westfalen, 46282, Germany|GSK Investigational Site, Eschweiler, Nordrhein-Westfalen, 52249, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45329, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45355, Germany|GSK Investigational Site, Goch, Nordrhein-Westfalen, 47574, Germany|GSK Investigational Site, Koeln, Nordrhein-Westfalen, 50823, Germany|GSK Investigational Site, Koeln, Nordrhein-Westfalen, 51069, Germany|GSK Investigational Site, Witten, Nordrhein-Westfalen, 58455, Germany|GSK Investigational Site, Ingelheim, Rheinland-Pfalz, 55218, Germany|GSK Investigational Site, Mainz, Rheinland-Pfalz, 55116, Germany|GSK Investigational Site, Rhaunen, Rheinland-Pfalz, 55624, Germany|GSK Investigational Site, Neunkirchen, Saarland, 66539, Germany|GSK Investigational Site, Koethen, Sachsen-Anhalt, 06366, Germany|GSK Investigational Site, Schoenebeck, Sachsen-Anhalt, 39218, Germany|GSK Investigational Site, Wolmirstedt, Sachsen-Anhalt, 39326, Germany|GSK Investigational Site, Zerbst, Sachsen-Anhalt, 39261, Germany|GSK Investigational Site, Borna, Sachsen, 04552, Germany|GSK Investigational Site, Delitzsch, Sachsen, 04509, Germany|GSK Investigational Site, Dresden, Sachsen, 01099, Germany|GSK Investigational Site, Dresden, Sachsen, 01307, Germany|GSK Investigational Site, Leipzg, Sachsen, 04109, Germany|GSK Investigational Site, Leipzig, Sachsen, 04103, Germany|GSK Investigational Site, Oschatz, Sachsen, 04758, Germany|GSK Investigational Site, Pirna, Sachsen, 01796, Germany|GSK Investigational Site, Berlin, 10367, Germany|GSK Investigational Site, Berlin, 10629, Germany|GSK Investigational Site, Berlin, 10787, Germany|GSK Investigational Site, Berlin, 13125, Germany|GSK Investigational Site, Berlin, 13158, Germany|GSK Investigational Site, Hamburg, 22177, Germany|GSK Investigational Site, Ahmedabad, 380006, India|GSK Investigational Site, Bangalore, 560 010, India|GSK Investigational Site, Bangalore, 560034, India|GSK Investigational Site, Banjara Hills PO, Hyderabad, 500 034, India|GSK Investigational Site, Belgaum, 590001, India|GSK Investigational Site, Chennai, 600 008, India|GSK Investigational Site, Chennai, 600 028, India|GSK Investigational Site, Cochin, 683572, India|GSK Investigational Site, Hyderabad, 500034, India|GSK Investigational Site, Karnal, 132001, India|GSK Investigational Site, Kerala, 688 524, India|GSK Investigational Site, Kochi, 682 040, India|GSK Investigational Site, Kochi, 682026, India|GSK Investigational Site, Kottyam, 686 027, India|GSK Investigational Site, Mumbai, 400007, India|GSK Investigational Site, Nasik, 422013, India|GSK Investigational Site, Nellore, 524001, India|GSK Investigational Site, Pune, 411004, India|GSK Investigational Site, Tamil Nadu, Trichy - 620 018, India|GSK Investigational Site, Trivandrum, 695607, India|GSK Investigational Site, Vijayawada, 520008, India|GSK Investigational Site, Milano (Milan), Lombardia, 20132, Italy|GSK Investigational Site, Sesto San Giovanni (MI), Lombardia, 20099, Italy|GSK Investigational Site, Pozzilli (IS), Molise, 86077, Italy|GSK Investigational Site, Chieri (Torino), 10023, Italy|GSK Investigational Site, Cesis, LV4100, Latvia|GSK Investigational Site, Daugavpils, LV5417, Latvia|GSK Investigational Site, Jekabpils, LV5201, Latvia|GSK Investigational Site, Liepaja, LV3401, Latvia|GSK Investigational Site, Riga, LV 1002, Latvia|GSK Investigational Site, Riga, LV 1011, Latvia|GSK Investigational Site, Riga, LV1024, Latvia|GSK Investigational Site, Tukums, LV 3100, Latvia|GSK Investigational Site, Tijuana, Baja California Norte, 22010, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44150, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44380, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44600, Mexico|GSK Investigational Site, Guadalajara, Jalisco, CP 44340, Mexico|GSK Investigational Site, Zapopan, Jalisco, 45200, Mexico|GSK Investigational Site, Morelia, Michoacán, Mexico|GSK Investigational Site, San Luis Potosi, San Luis Potosí, 78200, Mexico|GSK Investigational Site, Aguascalientes, 20230, Mexico|GSK Investigational Site, Guadalajara, Mexico|GSK Investigational Site, Tampico, Mexico|GSK Investigational Site, Amsterdam, 1061 AE, Netherlands|GSK Investigational Site, Heerlen, 6419 PC, Netherlands|GSK Investigational Site, Hoofddorp, 2134, Netherlands|GSK Investigational Site, Rotterdam, 3015 CE, Netherlands|GSK Investigational Site, Rotterdam, 3045 PM, Netherlands|GSK Investigational Site, Bodø, 8005, Norway|GSK Investigational Site, Hoenefoss, 3513, Norway|GSK Investigational Site, Kløfta, 2040, Norway|GSK Investigational Site, Oslo, 0160, Norway|GSK Investigational Site, Oslo, 0319, Norway|GSK Investigational Site, Oslo, 0514, Norway|GSK Investigational Site, Skedsmokorset, N-2020, Norway|GSK Investigational Site, Stavanger, 4005, Norway|GSK Investigational Site, Tromsø, 9038, Norway|GSK Investigational Site, Trondheim, 7212, Norway|GSK Investigational Site, Faisalabad, 37250, Pakistan|GSK Investigational Site, Islamabad, 44000, Pakistan|GSK Investigational Site, Lahore, 54000, Pakistan|GSK Investigational Site, Arequipa, 54, Peru|GSK Investigational Site, Laoag City, 2900, Philippines|GSK Investigational Site, Bacau, 600114, Romania|GSK Investigational Site, Baia Mare, 435400, Romania|GSK Investigational Site, Bistrita, 420016, Romania|GSK Investigational Site, Brasov, 500365, Romania|GSK Investigational Site, Bucuresti, 020475, Romania|GSK Investigational Site, Buzau, 120203, Romania|GSK Investigational Site, Deva, 330084, Romania|GSK Investigational Site, Iasi, 700547, Romania|GSK Investigational Site, Oradea, 410469, Romania|GSK Investigational Site, Pitesti, 110084, Romania|GSK Investigational Site, Sibiu, 550245, Romania|GSK Investigational Site, Arkhangelsk, 163045, Russian Federation|GSK Investigational Site, Barnaul, 656 045, Russian Federation|GSK Investigational Site, Barnaul, 656038, Russian Federation|GSK Investigational Site, Barnaul, 656055, Russian Federation|GSK Investigational Site, Ivanovo, 153012, Russian Federation|GSK Investigational Site, Ivanovo, 153462, Russian Federation|GSK Investigational Site, Kazan, 420012, Russian Federation|GSK Investigational Site, Kazan, 420033, Russian Federation|GSK Investigational Site, Kemerovo, 650000, Russian Federation|GSK Investigational Site, Kemerovo, 650002, Russian Federation|GSK Investigational Site, Kemerovo, 650036, Russian Federation|GSK Investigational Site, Kirov, 610030, Russian Federation|GSK Investigational Site, Kursk, 305035, Russian Federation|GSK Investigational Site, Moscow, 111539, Russian Federation|GSK Investigational Site, Moscow, 115487, Russian Federation|GSK Investigational Site, Moscow, 117 036, Russian Federation|GSK Investigational Site, Moscow, 117556, Russian Federation|GSK Investigational Site, Moscow, 121 552, Russian Federation|GSK Investigational Site, Moscow, 121552, Russian Federation|GSK Investigational Site, Moscow, 123448, Russian Federation|GSK Investigational Site, Moscow, 125367, Russian Federation|GSK Investigational Site, Moscow, 129110, Russian Federation|GSK Investigational Site, Nizhniy Novgorod, 603076, Russian Federation|GSK Investigational Site, Nizhniy Novgorod, 603126, Russian Federation|GSK Investigational Site, Nizhny Novgorod, 603003, Russian Federation|GSK Investigational Site, Ryazan, 390026, Russian Federation|GSK Investigational Site, Saint-Petersburg, 197341, Russian Federation|GSK Investigational Site, Saint-Petersburg, 198260, Russian Federation|GSK Investigational Site, Saratov, 410031, Russian Federation|GSK Investigational Site, Smolensk, 214 019, Russian Federation|GSK Investigational Site, St Pertersburg, 196247, Russian Federation|GSK Investigational Site, St Petersberg, 192288, Russian Federation|GSK Investigational Site, St'Petersburg, 194156, Russian Federation|GSK Investigational Site, St'Petersburg, 197110, Russian Federation|GSK Investigational Site, St-Petersburg, 193312, Russian Federation|GSK Investigational Site, St-Petersburg, 194017, Russian Federation|GSK Investigational Site, St-Petersburg, 195067, Russian Federation|GSK Investigational Site, St-Petersburg, 195197, Russian Federation|GSK Investigational Site, St. Petersburg, 197758, Russian Federation|GSK Investigational Site, St. Petersburg, 198205, Russian Federation|GSK Investigational Site, Syktyvkar, 167 981, Russian Federation|GSK Investigational Site, Tomsk, 634012, Russian Federation|GSK Investigational Site, Tomsk, 634050, Russian Federation|GSK Investigational Site, Tomsk, 634063, Russian Federation|GSK Investigational Site, Vladivostok, 690034, Russian Federation|GSK Investigational Site, Vladivostok, 690105, Russian Federation|GSK Investigational Site, Volgograd, 400008, Russian Federation|GSK Investigational Site, Voronezh, 394018, Russian Federation|GSK Investigational Site, Yaroslavl, 150003, Russian Federation|GSK Investigational Site, Bratislava, 826 06, Slovakia|GSK Investigational Site, Bratislava, 831 01, Slovakia|GSK Investigational Site, Nitra, 949 11, Slovakia|GSK Investigational Site, Port Elizabeth, Eastern Cape, 6014, South Africa|GSK Investigational Site, Meyerspark, Gauteng, 0184, South Africa|GSK Investigational Site, Parktown, Gauteng, 2193, South Africa|GSK Investigational Site, Chatsworth, KwaZulu- Natal, 4092, South Africa|GSK Investigational Site, Umhlanga Rocks, KwaZulu- Natal, 4320, South Africa|GSK Investigational Site, Bellville, 7531, South Africa|GSK Investigational Site, Benoni, 1501, South Africa|GSK Investigational Site, Bloemfontein, 9301, South Africa|GSK Investigational Site, Cape Town, 7500, South Africa|GSK Investigational Site, Cape Town, 7800, South Africa|GSK Investigational Site, Durban, 4001, South Africa|GSK Investigational Site, Newton, 2113, South Africa|GSK Investigational Site, Observatory, 7925, South Africa|GSK Investigational Site, Parktown, 2193, South Africa|GSK Investigational Site, Pretoria, 0002, South Africa|GSK Investigational Site, Somerset West, 7130, South Africa|GSK Investigational Site, Soweto, 1111, South Africa|GSK Investigational Site, Soweto, 2013, South Africa|GSK Investigational Site, Worcester, 6850, South Africa|GSK Investigational Site, Eksjö, SE-575 36, Sweden|GSK Investigational Site, Göteborg, SE-413 45, Sweden|GSK Investigational Site, Göteborg, SE-416 85, Sweden|GSK Investigational Site, Göteborg, SE-417 17, Sweden|GSK Investigational Site, Härnösand, SE-871 82, Sweden|GSK Investigational Site, Karlshamn, SE-374 80, Sweden|GSK Investigational Site, Kristianstad, SE-291 85, Sweden|GSK Investigational Site, Ljungby, SE-341 82, Sweden|GSK Investigational Site, Malmö, SE-205 02, Sweden|GSK Investigational Site, Malmö, SE-214 22, Sweden|GSK Investigational Site, Oskarshamn, SE-572 28, Sweden|GSK Investigational Site, Skene, SE-511 62, Sweden|GSK Investigational Site, Stockholm, SE-111 57, Sweden|GSK Investigational Site, Stockholm, SE-171 76, Sweden|GSK Investigational Site, Vällingby, SE-162 68, Sweden|GSK Investigational Site, Växjö, SE-351 85, Sweden|GSK Investigational Site, Bangkok, 10400, Thailand|GSK Investigational Site, Bath, Somerset, BA1 3NG, United Kingdom|GSK Investigational Site, Chippenham, SN15 2SB, United Kingdom|GSK Investigational Site, Doncaster, DN9 1EP, United Kingdom|GSK Investigational Site, Harrogate, HG1 5JP, United Kingdom|GSK Investigational Site, London, E1 1BB, United Kingdom|GSK Investigational Site, Manchester, M13 9Wl, United Kingdom|GSK Investigational Site, Sheffield, S10 2RX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00879970