Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Vital Signs and ECG - Screening

- 20/09/2021 - 1 Formulaire, 5 Groupes Item, 28 Eléments de données, 1 Langue

Groupes Item: Patient identification, Vital signs, 12 lead ECG, Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report

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

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Vital Signs and ECG - Predose and Post- dose

- 21/08/2018 - 1 Formulaire, 6 Groupes Item, 29 Eléments de données, 1 Langue

Groupes Item: Electrocardiography; Pharmaceutical Preparations; Dosage; Date in time; Time, Electrocardiography; Pre-dose, Electrocardiography; Post-dose, Vital signs | Pharmaceutical Preparations | Dosage | Date in time | Time, Vital signs; Pre-dose, Vital signs; Post-dose

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

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Holter results - Pre- dose and 24h Post- dose

- 21/08/2018 - 1 Formulaire, 1 Groupe Item, 3 Eléments de données, 1 Langue

Groupe Item: Holter Electrocardiography; EKG finding

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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 27/09/2021 - 1 Formulaire, 8 Groupes Item, 98 Eléments de données, 1 Langue

Groupes Item: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities

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 information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 20/09/2021 - 1 Formulaire, 8 Groupes Item, 58 Eléments de données, 1 Langue

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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG (Screening)

- 23/01/2019 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Administrative Data, 12-Lead Electrocardiogram, 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 information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed 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 - 12-Lead ECG Form

- 23/01/2019 - 1 Formulaire, 2 Groupes Item, 12 Eléments de données, 1 Langue

Groupes Item: Administrative Data, 12-Lead Electrocardiogram

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 is for documentation of the ECG. It should be filled out at each study visit. 3 measurements will be taken Pre dose on Day 1, the baseline will be considered the mean of the 3 measurements on day 1. 1 measurement will be taken post dose on day 2 and 3. Unscheduled ECGs should be documented in this form whenever they are performed during the study. 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 - Unscheduled 12-Lead ECG Form

- 23/01/2019 - 1 Formulaire, 2 Groupes Item, 8 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Unscheduled 12-Lead Electrocardiogram

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 Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. 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 - Vital Signs and ECG - Follow up

- 21/08/2018 - 1 Formulaire, 2 Groupes Item, 12 Eléments de données, 1 Langue

Groupes Item: Vital signs, 12 lead ECG

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Unscheduled

- 08/12/2019 - 1 Formulaire, 7 Groupes Item, 45 Eléments de données, 1 Langue

Groupes Item: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality

Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

- 03/08/2017 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 1 Langue

Groupes Item: dextrometorphan urine collection, vital signs, 12-lead ecg, clinical chemistry and hematology, urinanalysis

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 7-10, Vital Signs 3, 12-Lead ECG Monitoring 3

- 30/07/2017 - 1 Formulaire, 3 Groupes Item, 19 Eléments de données, 1 Langue

Groupes Item: dosing details, vital signs, 12-lead ecg

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 7-10, Vital Signs 3, 12-Lead ECG Monitoring 3

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