PPAR - Combination With Metformin
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
1 other identifier
interventional
534
12 countries
203
Brief Summary
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus
Started Jun 2003
Shorter than P25 for phase_3 diabetes-mellitus
203 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
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedApril 27, 2012
April 1, 2012
September 9, 2005
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin
Secondary Outcomes (1)
change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes
- HbA1c \> - 7.0% and \< - 10.0 %
- Mean serum triglyceride \< - 600 mg/dL
- Body mass index \< - 41 kg/m2
- Fasting c-peptide \> - 1.0 ng/mL
You may not qualify if:
- History of myocardial infarction (MI)
- coronary angioplasty or bypass graft(s)
- valvular disease or repair
- unstable angina pectoris
- transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
- Congestive heart failure NYHA Class III and IV
- Uncontrolled hypertension
- History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (203)
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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Haleyville, Alabama, United States
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Mobile, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fayette, Arkansas, United States
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Little Rock, Arkansas, United States
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Concord, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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Mission Viejo, California, United States
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Pasadena, California, United States
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Rolling Hills Estate, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Loveland, Colorado, United States
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Wheat Ridge, Colorado, United States
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New Britain, Connecticut, United States
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Newark, Delaware, United States
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Wilmington, Delaware, United States
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Chipley, Florida, United States
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Cooper City, Florida, United States
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Kissimmee, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Columbus, Georgia, United States
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Dunwoody, Georgia, United States
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Honolulu, Hawaii, United States
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Overland Park, Kansas, United States
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Shawnee Mission, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Richmond, Kentucky, United States
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Slidell, Louisiana, United States
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Chester, Maryland, United States
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Silver Spring, Maryland, United States
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Ayer, Massachusetts, United States
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Springfield, Massachusetts, United States
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Sudbury, Massachusetts, United States
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Lansing, Michigan, United States
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Arden Hills, Minnesota, United States
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Gulfport, Mississippi, United States
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Olive Branch, Mississippi, United States
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Rolling Fork, Mississippi, United States
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City of Saint Peters, Missouri, United States
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Excelsior Springs, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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New Hyde Park, New York, United States
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West Seneca, New York, United States
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Westfield, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Huntersville, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Corvallis, Oregon, United States
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Eugene, Oregon, United States
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Hillsboro, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Duncan, South Carolina, United States
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Greer, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Lake Jackson, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Springfield, Virginia, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Bahía Blanca, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Canberra, New South Wales, Australia
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Sydney, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Perth, Western Australia, Australia
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Curitiba, Paraná, Brazil
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Belém, Pará, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Calgary, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Manuels, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Fleurimont, Quebec, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Albens, France
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Broglie, France
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Chartres, France
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Fabrègues, France
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Gémenos, France
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Husseren-Wesserling, France
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Labarthe-sur-Lèze, France
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Rosiers-d'Égletons, France
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Durango, Durango, Mexico
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Tijuana, Estado de Baja California, Mexico
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León, Guanajuato, Mexico
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Mérida, Yucatán, Mexico
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Añasco, Puerto Rico
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Carolina, Puerto Rico
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Guaynabo, Puerto Rico
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Ponce, Puerto Rico
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Rio Piedras, Puerto Rico
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Seoul, South Korea
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Ängelholm, Sweden
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Bjuv, Sweden
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Enskede, Sweden
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Farsta, Sweden
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Gothenburg, Sweden
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Helsingborg, Sweden
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Jarfalla, Sweden
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Landskrona, Sweden
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Leksand, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Ödeshög, Sweden
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Sävedalen, Sweden
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Sjuntorp, Sweden
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Stockholm, Sweden
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Trollhättan, Sweden
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Vällingby, Sweden
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Carrickfergus, Antrim, United Kingdom
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Soham, Cambridgeshire, United Kingdom
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Doncaster, Derbyshire, United Kingdom
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Paignton, Devon, United Kingdom
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Bangor, Down, United Kingdom
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Downpatrick, Down, United Kingdom
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Bexhill-on-Sea, East Sussex, United Kingdom
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High Valleyfield, Fife, United Kingdom
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Sunbury-on-Thames, Greater London, United Kingdom
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Aldershot, Hampshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Farnworth, Lancashire, United Kingdom
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Harrow, Middlesex, United Kingdom
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Doncaster, North Yorkshire, United Kingdom
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Hastings, Sussex, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Nuneaton, Warwickshire, United Kingdom
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Bath, Wiltshire, United Kingdom
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Inkberrow, Worcestershire, United Kingdom
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Swan Lake, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
June 1, 2003
Study Completion
May 1, 2004
Last Updated
April 27, 2012
Record last verified: 2012-04