Bipolar Study in Adults at Least 18 Years of Age
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00067938 |
Recruitment Status :
Completed
First Posted : September 5, 2003
Last Update Posted : September 1, 2016
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Bipolar study of tolerability, clinical response and patient satisfaction
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Drug: lamotrigine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness. |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | August 2004 |
Actual Study Completion Date : | August 2004 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Bipolar disorder
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Lamotrigine
Arm | Intervention/treatment |
---|---|
Arm 1
Open label single arm study
|
Drug: lamotrigine
Lamotrigine |
Primary Outcome Measures :
- The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures :
- Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [ Time Frame: 12 Weeks ]
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of bipolar I disorder.
- Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
- If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
Exclusion Criteria:
- Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
- Presence of untreated thyroid disease.
- Patient is actively suicidal or homicidal.
- Patient has history of severe hepatic or renal insufficiency.
- Patient is currently participating in another clinical trial.
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067938
Locations


United States, Alabama | |
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Albertville, Alabama, United States, 35950 | |
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Anniston, Alabama, United States, 36207 | |
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Birmingham, Alabama, United States, 35209 | |
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Birmingham, Alabama, United States, 35223 | |
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Birmingham, Alabama, United States, 35234 | |
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Fairhope, Alabama, United States, 36532 | |
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Huntsville, Alabama, United States, 35802 | |
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Tuscaloosa, Alabama, United States, 35404 | |
United States, Arizona | |
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Chandler, Arizona, United States, 85225 | |
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Phoenix, Arizona, United States, 85004 | |
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Phoenix, Arizona, United States, 85018 | |
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Phoenix, Arizona, United States, 85032 | |
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Phoenix, Arizona, United States, 85044 | |
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Rogers, Arizona, United States, 72756 | |
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Tucson, Arizona, United States, 85719 | |
United States, Arkansas | |
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Fort Smith, Arkansas, United States, 72903 | |
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Little Rock, Arkansas, United States, 72201 | |
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North Little Rock, Arkansas, United States, 72113 | |
United States, California | |
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Bakersfield, California, United States, 93309 | |
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Beverly Hills, California, United States, 90210 | |
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Burbank, California, United States, 91501 | |
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Campbell, California, United States, 95008 | |
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Cerritos, California, United States, 90703 | |
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El Centro, California, United States, 92243 | |
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Fairfield, California, United States, 94533 | |
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La Mesa, California, United States, 91941 | |
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Laguna Hills, California, United States, 92653 | |
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Los Angeles, California, United States, 90011 | |
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Los Angeles, California, United States, 90089 | |
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Oceanside, California, United States, 92056 | |
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Petaluma, California, United States, 94952 | |
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Poway, California, United States, 92064 | |
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Riverside, California, United States, 92506 | |
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Sacramento, California, United States, 95825 | |
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San Diego, California, United States, 92103 | |
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San Diego, California, United States, 92114 | |
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San Diego, California, United States, 92123 | |
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San Jose, California, United States, 95123 | |
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Santa Ana, California, United States, 92705 | |
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Santa Barbara, California, United States, 93102 | |
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Sherman Oaks, California, United States, 91403 | |
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Torrance, California, United States, 90505 | |
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West Hollywood, California, United States, 90048 | |
United States, Colorado | |
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Boulder, Colorado, United States, 80303 | |
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Fort Collins, Colorado, United States, 80525 | |
United States, Connecticut | |
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Hamden, Connecticut, United States, 06514 | |
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Mansfield Center, Connecticut, United States, 06250 | |
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Norwich, Connecticut, United States, 06360 | |
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Wethersfield, Connecticut, United States, 06109 | |
United States, Delaware | |
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Newark, Delaware, United States, 19713 | |
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Wilmington, Delaware, United States, 19808 | |
United States, District of Columbia | |
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Washington, District of Columbia, United States, 20011 | |
United States, Florida | |
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Altamonte Springs, Florida, United States, 32714 | |
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Boca Raton, Florida, United States, 33432 | |
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Boca Raton, Florida, United States, 33433 | |
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Boynton Beach, Florida, United States, 33426 | |
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Bradenton, Florida, United States, 34209 | |
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Brandon, Florida, United States, 33511 | |
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Casselberry, Florida, United States, 32730 | |
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Clearwater, Florida, United States, 33764 | |
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Coral Springs, Florida, United States, 33065 | |
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Davie, Florida, United States, 33024 | |
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Daytona Beach, Florida, United States, 32114 | |
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Destin, Florida, United States, 32541 | |
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Fort Walton Beach, Florida, United States, 32548 | |
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Gainesville, Florida, United States, 32607 | |
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Jacksonville Beach, Florida, United States, 32250 | |
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Jacksonville, Florida, United States, 32216 | |
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Jacksonville, Florida, United States, 32257 | |
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Lakeland, Florida, United States, 33803 | |
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Miami, Florida, United States, 32216 | |
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Miami, Florida, United States, 33125 | |
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Miami, Florida, United States, 33157 | |
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Miami, Florida, United States, 33176 | |
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North Miami, Florida, United States, 33161 | |
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Ocala, Florida, United States, 34471 | |
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Ocala, Florida, United States, 34474 | |
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Orange City, Florida, United States, 32763 | |
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Orlando, Florida, United States, 32803 | |
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Palm Beach Gardens, Florida, United States, 33410 | |
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Pensacola, Florida, United States, 32503 | |
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Plantation, Florida, United States, 33324 | |
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Sarasota, Florida, United States, 34238 | |
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St. Petersburg, Florida, United States, 33701 | |
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St. Petersburg, Florida, United States, 33702 | |
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Syracuse, Florida, United States, 13202 | |
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Tampa, Florida, United States, 33603 | |
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West Palm Beach, Florida, United States, 33407 | |
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Wilton Manors, Florida, United States, 33311 | |
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Winter Park, Florida, United States, 32789 | |
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Winter Park, Florida, United States, 32792 | |
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Zephyrhills, Florida, United States, 33540 | |
United States, Georgia | |
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Atlanta, Georgia, United States, 30030 | |
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Atlanta, Georgia, United States, 30309-7520 | |
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Atlanta, Georgia, United States, 30338 | |
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Decatur, Georgia, United States, 30030 | |
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Lawrenceville, Georgia, United States, 30045 | |
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Macon, Georgia, United States, 31201 | |
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Roswell, Georgia, United States, 30075 | |
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Stockbridge, Georgia, United States, 30281 | |
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Warner Robins, Georgia, United States, 31093 | |
United States, Idaho | |
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Boise, Idaho, United States, 83702 | |
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Boise, Idaho, United States, 83704 | |
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Boise, Idaho, United States, 83706 | |
United States, Illinois | |
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Alton, Illinois, United States, 62002 | |
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Bourbonnais, Illinois, United States, 60914 | |
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Chicago, Illinois, United States, 60657 | |
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East Moline, Illinois, United States, 61244 | |
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Evergreen Park, Illinois, United States, 60805 | |
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Fairview Heights, Illinois, United States, 62208 | |
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Granite City, Illinois, United States, 62040 | |
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Joliet, Illinois, United States, 60435 | |
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Libertyville, Illinois, United States, 60048 | |
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Lisle, Illinois, United States, 60532 | |
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Oakbrook Terrace, Illinois, United States, 60181 | |
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Orland Park, Illinois, United States, 60462 | |
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Park Ridge, Illinois, United States, 60068 | |
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Rockford, Illinois, United States, 61108 | |
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Schaumburg, Illinois, United States, 60194 | |
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Vernon Hills, Illinois, United States, 60061 | |
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Wheaton, Illinois, United States, 60187 | |
United States, Indiana | |
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Danville, Indiana, United States, 46122 | |
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Evansville, Indiana, United States, 47715 | |
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Fort Wayne, Indiana, United States, 46805 | |
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Lafayette, Indiana, United States, 47904 | |
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Mishawaka, Indiana, United States, 46545 | |
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Plymouth, Indiana, United States, 46563 | |
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Valparaiso, Indiana, United States, 46383 | |
United States, Iowa | |
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Cedar Rapids, Iowa, United States, 52402 | |
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Dubuque, Iowa, United States, 52001 | |
United States, Kansas | |
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Leavenworth, Kansas, United States, 66048 | |
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Overland Park, Kansas, United States, 66211 | |
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Shawnee Mission, Kansas, United States, 66214 | |
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Topeka, Kansas, United States, 66606 | |
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Wichita, Kansas, United States, 67205 | |
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Wichita, Kansas, United States, 67206 | |
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Wichita, Kansas, United States, 67207 | |
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Wichita, Kansas, United States, 67211 | |
United States, Kentucky | |
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Hopkinsville, Kentucky, United States, 42240 | |
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Lexington, Kentucky, United States, 40509 | |
United States, Louisiana | |
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Baton Rouge, Louisiana, United States, 70806 | |
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Houma, Louisiana, United States, 70360 | |
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Lake Charles, Louisiana, United States, 70601 | |
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Shreveport, Louisiana, United States, 71101 | |
United States, Maryland | |
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Annapolis, Maryland, United States, 21403 | |
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Baltimore, Maryland, United States, 21239 | |
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Batlimore, Maryland, United States, 21208 | |
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Burtonsville, Maryland, United States, 20866 | |
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Ellicott City, Maryland, United States, 21043 | |
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Gaithersburg, Maryland, United States, 20877 | |
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Glen Burnie, Maryland, United States, 21061 | |
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Laurel, Maryland, United States, 20707 | |
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Rockville, Maryland, United States, 20852 | |
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Towson, Maryland, United States, 21204 | |
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Towson, Maryland, United States, 21286 | |
United States, Michigan | |
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Adrian, Michigan, United States, 49221 | |
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Bay City, Michigan, United States, 48706 | |
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Benton Harbor, Michigan, United States, 49022 | |
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Bloomfield Hills, Michigan, United States, 48302 | |
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Brownstown Township, Michigan, United States, 48183 | |
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Clinton Township, Michigan, United States, 48036 | |
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East Lansing, Michigan, United States, 48823 | |
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Farmington Hills, Michigan, United States, 48334 | |
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Flint, Michigan, United States, 48507 | |
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Flint, Michigan, United States, 48532 | |
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Mount Clemens, Michigan, United States, 48043 | |
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Rochester Hills, Michigan, United States, 48307 | |
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Royal Oak, Michigan, United States, 48067 | |
United States, Minnesota | |
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Duluth, Minnesota, United States, 55802 | |
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Minneapolis, Minnesota, United States, 55454 | |
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Oakdale, Minnesota, United States, 55128 | |
United States, Mississippi | |
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Flowood, Mississippi, United States, 39232 | |
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Gulfport, Mississippi, United States, 39503 | |
United States, Missouri | |
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Joplin, Missouri, United States, 64804 | |
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Kansas City, Missouri, United States, 64108 | |
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Springfield, Missouri, United States, 65804 | |
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St. Charles, Missouri, United States, 63301 | |
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St. Louis, Missouri, United States, 63117 | |
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St. Louis, Missouri, United States, 63128 | |
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St. Louis, Missouri, United States, 63136-3675 | |
United States, Montana | |
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Billings, Montana, United States, 59101 | |
United States, Nebraska | |
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Lincoln, Nebraska, United States, 68502 | |
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Omaha, Nebraska, United States, 68124 | |
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Omaha, Nebraska, United States, 68131 | |
United States, Nevada | |
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Henderson, Nevada, United States, 89074 | |
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Las Vegas, Nevada, United States, 89030 | |
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Las Vegas, Nevada, United States, 89102 | |
United States, New Hampshire | |
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Manchester, New Hampshire, United States, 03104 | |
United States, New Jersey | |
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Long Branch, New Jersey, United States, 07740 | |
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Princeton, New Jersey, United States, 08540 | |
United States, New Mexico | |
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Albuquerque, New Mexico, United States, 87108 | |
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Las Cruces, New Mexico, United States, 88011 | |
United States, New York | |
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Albany, New York, United States, 31701 | |
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Amityville, New York, United States, 11701 | |
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Bronx, New York, United States, 10461 | |
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Farmingdale, New York, United States, 11735 | |
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Latham, New York, United States, 12110 | |
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New Rochelle, New York, United States, 10801 | |
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New York, New York, United States, 10023 | |
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Olean, New York, United States, 14760 | |
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Port Jefferson, New York, United States, 11777 | |
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Smithtown, New York, United States, 11787 | |
United States, North Carolina | |
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Cary, North Carolina, United States, 27511 | |
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Chapel Hill, North Carolina, United States, 27514 | |
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Chapel Hill, North Carolina, United States, 27517 | |
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Charlotte, North Carolina, United States, 28211 | |
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Cornelius, North Carolina, United States, 28031 | |
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Durham, North Carolina, United States, 27705 | |
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Fayetteville, North Carolina, United States, 28305 | |
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Forest City, North Carolina, United States, 28043 | |
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Goldsboro, North Carolina, United States, 27530 | |
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Greensboro, North Carolina, United States, 27408 | |
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Greenville, North Carolina, United States, 27834 | |
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Greenville, North Carolina, United States, 27858 | |
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High Point, North Carolina, United States, 27262 | |
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Raleigh, North Carolina, United States, 27605 | |
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Raleigh, North Carolina, United States, 27607 | |
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Raleigh, North Carolina, United States, 27609 | |
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Raleigh, North Carolina, United States, 27612 | |
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Wilmington, North Carolina, United States, 28401 | |
United States, Ohio | |
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Avon Lake, Ohio, United States, 44012 | |
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Cincinnati, Ohio, United States, 45206 | |
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Cincinnati, Ohio, United States, 45243 | |
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Cuyahoga Falls, Ohio, United States, 44221 | |
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Dayton, Ohio, United States, 45459 | |
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Warren, Ohio, United States, 44483 | |
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Youngstown, Ohio, United States, 44512 | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States, 73103 | |
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Oklahoma City, Oklahoma, United States, 73109 | |
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Oklahoma City, Oklahoma, United States, 73118 | |
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Oklahoma City, Oklahoma, United States, 73120 | |
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Tulsa, Oklahoma, United States, 74120 | |
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Tulsa, Oklahoma, United States, 74136 | |
United States, Oregon | |
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Milwaukie, Oregon, United States, 97222 | |
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Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
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Colmar, Pennsylvania, United States, 18915 | |
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Doyletown, Pennsylvania, United States, 18901 | |
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Kingston, Pennsylvania, United States, 18704 | |
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McKeesport, Pennsylvania, United States, 15132 | |
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Media, Pennsylvania, United States, 19063 | |
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Natrona Heights, Pennsylvania, United States, 15065 | |
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Philadelphia, Pennsylvania, United States, 19139 | |
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Pittsburgh, Pennsylvania, United States, 15243 | |
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Reading, Pennsylvania, United States, 19610 | |
United States, South Carolina | |
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Charleston, South Carolina, United States, 29407 | |
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Moncks Corner, South Carolina, United States, 29461 | |
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North Charleston, South Carolina, United States, 29406 | |
United States, Tennessee | |
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Bristol, Tennessee, United States, 37620 | |
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Cordova, Tennessee, United States, 38016 | |
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Johnson City, Tennessee, United States, 37601 | |
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Kingsport, Tennessee, United States, 37664 | |
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Knoxville, Tennessee, United States, 37919 | |
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Knoxville, Tennessee, United States, 37922 | |
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Madison, Tennessee, United States, 37115 | |
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Murfreesboro, Tennessee, United States, 37129 | |
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Nashville, Tennessee, United States, 37203 | |
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Nashville, Tennessee, United States, 37204 | |
United States, Texas | |
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Arlington, Texas, United States, 76012 | |
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Austin, Texas, United States, 78759 | |
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Bedford, Texas, United States, 76022 | |
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Conroe, Texas, United States, 77304 | |
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Dallas, Texas, United States, 75219 | |
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Houston, Texas, United States, 77007 | |
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Houston, Texas, United States, 77014 | |
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Houston, Texas, United States, 77027 | |
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Houston, Texas, United States, 77030 | |
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Houston, Texas, United States, 77042 | |
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Houston, Texas, United States, 77057 | |
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Houston, Texas, United States, 77074 | |
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Humble, Texas, United States, 77338 | |
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Humble, Texas, United States, 77339 | |
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Irving, Texas, United States, 75062 | |
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Kingwood, Texas, United States, 77339 | |
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Nacogdoches, Texas, United States, 75965 | |
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San Antonio, Texas, United States, 78229 | |
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San Antonio, Texas, United States, 78232 | |
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Sugar Land, Texas, United States, 77478 | |
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Tyler, Texas, United States, 75702 | |
United States, Utah | |
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Salt Lake City, Utah, United States, 84102 | |
United States, Vermont | |
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Williston, Vermont, United States, 04495 | |
United States, Virginia | |
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Arlington, Virginia, United States, 22205 | |
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Ashburn, Virginia, United States, 20147 | |
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Charlottesville, Virginia, United States, 22903 | |
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Charlottesville, Virginia, United States, 22911 | |
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Christiansburg, Virginia, United States, 24073 | |
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Danville, Virginia, United States, 24541 | |
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Falls Church, Virginia, United States, 22041 | |
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Midlothian, Virginia, United States, 23112 | |
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Newport News, Virginia, United States, 23606 | |
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Norfolk, Virginia, United States, 23505 | |
GSK Investigational Site | |
Portsmouth, Virginia, United States, 23703 | |
GSK Investigational Site | |
Richmond, Virginia, United States, 23230 | |
GSK Investigational Site | |
Suffolk, Virginia, United States, 23434 | |
GSK Investigational Site | |
Virginia Beach, Virginia, United States, 23452 | |
United States, Washington | |
GSK Investigational Site | |
Bellingham, Washington, United States, 98225 | |
GSK Investigational Site | |
Everett, Washington, United States, 98201 | |
GSK Investigational Site | |
Renton, Washington, United States, 98055 | |
GSK Investigational Site | |
Spokane, Washington, United States, 99204 | |
GSK Investigational Site | |
Tacoma, Washington, United States, 98499 | |
United States, West Virginia | |
GSK Investigational Site | |
Charleston, West Virginia, United States, 25301 | |
GSK Investigational Site | |
Charleston, West Virginia, United States, 25309 | |
GSK Investigational Site | |
Weirton, West Virginia, United States, 26062 | |
United States, Wisconsin | |
GSK Investigational Site | |
Mequion, Wisconsin, United States, 53092 | |
GSK Investigational Site | |
Milwaukee, Wisconsin, United States, 53226 | |
GSK Investigational Site | |
Racine, Wisconsin, United States, 53403 | |
GSK Investigational Site | |
Waukesha, Wisconsin, United States, 53188 | |
GSK Investigational Site | |
Wauwatosa, Wisconsin, United States, 53213 | |
GSK Investigational Site | |
West Allis, Wisconsin, United States, 53227 |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Clinical Study Report
Study Data/Documents: Clinical Study Report

Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol


Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set


Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification


Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form


Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan


Identifier: SCA40917
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00067938 |
Other Study ID Numbers: |
SCA40917 |
First Posted: | September 5, 2003 Key Record Dates |
Last Update Posted: | September 1, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
bipolar disorder lamotrigine |
Additional relevant MeSH terms:
Bipolar Disorder Bipolar and Related Disorders Mental Disorders Lamotrigine Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |