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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Psychiatric History

- 17-11-19 - 1 Formulier, 2 Itemgroepen, 92 Data-elementen, 1 Taal
Itemgroepen: Psychiatric History, Psychiatric History, Mental disorder, Other
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Medical History Update

- 11-01-19 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Medical History Update, Conclusion
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form records updates in the medical history of the subject. It should be checked at each visit after the screening. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Medical History

- 10-01-19 - 1 Formulier, 4 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Medical History, Medical History Continuation, Conclusion
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains the subject's medical history. It should be filled out at the screening visit, and updated at each treatment period. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Non- Serious and Serious Adverse Event

- 27-08-18 - 1 Formulier, 7 Itemgroepen, 51 Data-elementen, 1 Taal
Itemgroepen: Non-serious Adverse Event, Serious Adverse Event, Pharmaceutical Preparations | Concomitant Therapy, Disease | risk factors, diagnostic procedure; Result, Experimental drug, Comment
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Visit 9 GSK Rosiglitazone Alzheimer's disease 100468

- 25-07-17 - 1 Formulier, 16 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: Central Laboratory Instructions, Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Neurological Examination, Central Laboratory, Pregnancy Test, 12-Lead ECG, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Rating Scale Instructions, Investigational Product/ Compliance, End of Visit Reminder
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 9

Visit 8 GSK Rosiglitazone Alzheimer's disease 100468

- 25-07-17 - 1 Formulier, 11 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product/ Compliance, End of Visit Reminder
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 8

Visit 6 GSK Rosiglitazone Alzheimer's disease 100468

- 25-07-17 - 1 Formulier, 16 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Central Laboratory Instructions, Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Neurological Examination, Central Laboratory, Pregnancy Test, 12-Lead ECG, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Rating Scale Instructions, Investigational Product/ Compliance, End of Visit Reminder
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 6

Visit 7 GSK Rosiglitazone Alzheimer's disease 100468

- 25-07-17 - 1 Formulier, 11 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product/ Compliance, End of Visit Reminder
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 7

Visit 5 GSK Rosiglitazone Alzheimer's disease 100468

- 20-06-17 - 1 Formulier, 10 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product/ Compliance
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 5

Visit 4 GSK Rosiglitazone Alzheimer's disease 100468

- 20-06-17 - 1 Formulier, 10 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product/ Compliance
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 4

Visit 3 GSK Rosiglitazone Alzheimer's disease 100468

- 20-06-17 - 1 Formulier, 10 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema, Investigational Product/ Compliance
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 3

Visit 2 GSK Rosiglitazone Alzheimer's disease 100468

- 20-06-17 - 1 Formulier, 9 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Visit Information, Investigator Instructions, Subject Continuation, Vital Signs, Central Laboratory, Concomitant Medication, Adverse Event, Physical Examination, Pedal Oedema
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 2

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