Study Stopped
The development program has been terminated
GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.
2 other identifiers
interventional
2,000
31 countries
277
Brief Summary
This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Mar 2005
277 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMarch 17, 2008
March 1, 2008
November 10, 2005
March 14, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary Outcomes (4)
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
C-reactive protein
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Interventions
Eligibility Criteria
You may qualify if:
- Provision of a written informed consent
- Men or women who are \>=18 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- Completed the last two visits of randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.
You may not qualify if:
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with chronic insulin
- History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above twice the normal range
- Creatine kinase above 3 times the upper limit of normal
- Previous enrollment in this long-term extension study
- Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (277)
Research Site
Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Mobile, Alabama, United States
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Carlisle, Arkansas, United States
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Sherwood, Arkansas, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Redondo Beach, California, United States
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Sacramento, California, United States
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Colorado Springs, Colorado, United States
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Wheat Ridge, Colorado, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Brunswick, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Evansville, Indiana, United States
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Witchita, Kansas, United States
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Bossier City, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Kalamazoo, Michigan, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Hamilton, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Simpsonville, South Carolina, United States
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Morristown, Tennessee, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Burke, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Menomonee Falls, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Morón, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Ciudad de Buenos Aires, Argentina
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Rosario, Argentina
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Salta - Salta, Argentina
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Adelaide, Australia
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Brisbane, Australia
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Cairns, Australia
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Geelong, Australia
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Melbourne, Australia
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Perth, Australia
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Sydney, Australia
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Tasmania, Australia
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Curitiba, Brazil
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Fortaleza, Brazil
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Goiânia, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Surrey, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Bolton, Ontario, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Hastings, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Napanee, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Smith Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Chomedey-Laval, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, Czechia
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Hodonín, Czechia
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Hradec Králové, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Příbram, Czechia
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Semily, Czechia
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Tábor, Czechia
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Ústí nad Labem, Czechia
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Paide, Estonia
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
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Hämeenlinna, Finland
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Helsinki, Finland
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Imatra, Finland
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Jakobstad, Finland
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Joensuu, Finland
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Kokkola, Finland
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Kouvola, Finland
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Kuopio, Finland
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Lahti, Finland
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Mikkeli, Finland
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Oulu, Finland
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Salo, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Turku, Finland
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Vaasa, Finland
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Vantaa, Finland
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Athens, Greece
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Piraeus, Greece
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Hong Kong, Hong Kong
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Balatonfüred, Hungary
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Budapest, Hungary
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Győr, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Siófok, Hungary
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Székesfehérvár, Hungary
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Bangalore, India
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Hyderabad, India
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Mumbai, India
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New Delhi, India
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Jakarta, Indonesia
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Malang, Indonesia
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Ashkelon, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Rishon LeZiyyon, Israel
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Safed, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Arenzano, Italy
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Chiavari (GE), Italy
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Chieri, Italy
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Florence, Italy
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Messina, Italy
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Milan, Italy
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Monteccio Emilia, Italy
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Napoli, Italy
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Padua, Italy
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Pescara, Italy
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Piacenza, Italy
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Pistoia, Italy
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Reggio Calabria, Italy
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Reggio Emilia, Italy
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Roma, Italy
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Scandiano, Italy
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Udine, Italy
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Daugavpils, Latvia
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Jēkabpils, Latvia
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Madona, Latvia
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Riga, Latvia
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Sigulda, Latvia
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Talsi, Latvia
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Valmiera, Latvia
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Vilnius, Lithuania
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Kubang Kerian, Kota Bharu, Malaysia
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Beek en Donk, Netherlands
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Bennebroek, Netherlands
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Deurne, Netherlands
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Huizen, Netherlands
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Losser, Netherlands
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Nijverdal, Netherlands
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Rijswijk, Netherlands
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Roelofarendsveen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Cebu City, Philippines
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Makati, Philippines
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Manila, Philippines
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Marikina City, Philippines
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Pasig, Philippines
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Quezon City, Philippines
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Katowice, Ochojec, Poland
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Poznan, Poland
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Radom, Poland
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Rzeszów, Poland
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Sopot, Poland
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Szczecin, Poland
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Toruñ, Poland
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Tychy, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Zielona Góra, Poland
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Almada, Portugal
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Amadora, Portugal
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Elvas, Portugal
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Lisbon, Portugal
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Portalegre, Portugal
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Moscow, Russia
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Saint Petersburg, Russia
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Yaroslavl, Russia
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Belgrade, Serbia and Montenegro
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Singapore, Singapore
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Dolný Kubín, Slovakia
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Levice, Slovakia
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Lučenec, Slovakia
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Ľubochňa, Slovakia
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Nové Zámky, Slovakia
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Považská Bystrica, Slovakia
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Šahy, Slovakia
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Trenčín, Slovakia
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Veľký Meder, Slovakia
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Žilina, Slovakia
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Cape Town, South Africa
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Chatsworth, South Africa
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Durban, South Africa
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Gauteng, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Seoul, South Korea
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Suwon, South Korea
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Bern, Switzerland
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Ilanz, Switzerland
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Lausanne, Switzerland
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Monthey, Switzerland
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Zurich, Switzerland
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Aberdeen, United Kingdom
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Atherstone, United Kingdom
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Ayr, United Kingdom
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Bath, United Kingdom
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Belfast, United Kingdom
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Berks, United Kingdom
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Birmingham, United Kingdom
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Bolton, United Kingdom
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Bucks, United Kingdom
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Cardiff, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Northampton, United Kingdom
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Plymouth, United Kingdom
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Radstock, United Kingdom
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Shrewsbury, United Kingdom
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Surrey, United Kingdom
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West Bromwich, United Kingdom
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Wiltshire, United Kingdom
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Wrexham, United Kingdom
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Galida Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
March 1, 2005
Study Completion
January 1, 2007
Last Updated
March 17, 2008
Record last verified: 2008-03