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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - ECG Abnormalities

- 11/11/18 - 1 modulo, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: 12 lead ECG, Abnormality

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - 12-Lead-ECG

- 06/11/18 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio

ItemGroup: 12-Lead-ECG

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Logs/Repeats

- 27/09/21 - 1 modulo, 12 itemgroups, 130 elementi, 1 linguaggio

Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Repeat, Pharmacokinetic aspect, Blood, Repeat

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Medical History, Physical Examination, Vital Signs and ECG (Screening)

- 20/09/21 - 1 modulo, 5 itemgroups, 39 elementi, 1 linguaggio

Itemgroups: Administrative Data, Medical Conditions, Physical Examination, Vital Signs, ECG

This ODM file contains the form to document the physical examination, ecg, vital signs and medical history. To be assessed at screening. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - V10

- 03/05/20 - 1 modulo, 24 itemgroups, 628 elementi, 1 linguaggio

Itemgroups: Date of visit, Experimental drug, Dextromethorphan, Therapeutic procedure, Confirmation, Blood Pressure Monitoring, Ambulatory, Cognitive functions, Tests, Holter Electrocardiography, Holter Electrocardiography, Abnormality, Telemetry, Telemetry, Abnormality, Laboratory Procedures, Pulmonary function tests, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Dextromethorphan, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Urine, Saliva specimen, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Vital signs, Respiratory rate

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - V12

- 03/05/20 - 1 modulo, 16 itemgroups, 138 elementi, 1 linguaggio

Itemgroups: Date of visit, Experimental drug, Therapeutic procedure, Confirmation, Blood Pressure Monitoring, Ambulatory, Cognitive functions, Tests, Holter Electrocardiography, Holter Electrocardiography, Abnormality, Telemetry, Telemetry, Abnormality, Laboratory Procedures, Pulmonary function tests, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Urine, Saliva specimen, Vital signs, Respiratory rate, Vital signs

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - V7

- 19/04/20 - 1 modulo, 11 itemgroups, 60 elementi, 1 linguaggio

Itemgroups: Date of visit, Cytochrome P450 2D6 Inhibitors [MoA], Status, Dextromethorphan, Therapeutic procedure, Confirmation, Blood Pressure Monitoring, Ambulatory, Cognitive functions, Tests, Holter Electrocardiography, Holter Electrocardiography, Abnormality, Laboratory Procedures, Pharmacokinetic aspects, Blood, Vital signs

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

GSK Ropinirole in Patients Suffering from Parkinsons Disease Early Withdrawal 101468/169 NCT00381472

- 17/09/17 - 1 modulo, 19 itemgroups, 42 elementi, 1 linguaggio

Itemgroups: DIARY INFORMATION, General Information, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, CENTRAL LABORATORY, 12-LEAD ECG, PREGNANCY TEST, VITAL SIGNS, CLINICAL GLOBAL IMPRESSION, UNIFIED PARKINSONS DISEASE RATING SCALE, PARKINSON’S DISEASE SLEEP SCALE (PDSS), BECK DEPRESSION INVENTORY, EPWORTH SLEEPINESS SCALE, PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE (PDQ-39), INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Early Withdrawal form.

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - ECG Abnormalities

- 17/09/21 - 1 modulo, 8 itemgroups, 93 elementi, 1 linguaggio

Itemgroups: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities

This form documents the recorded abnormalities on ECG. To be filled in continously. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963 - Period 2 Day 64

- 22/04/19 - 1 modulo, 9 itemgroups, 41 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Vital Signs, Chemistry, Clinical, Hematologic tests, Urinalysis, 12 lead ECG, Electrocardiography, Experimental drug, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 20/09/21 - 1 modulo, 16 itemgroups, 156 elementi, 1 linguaggio

Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Estimation of Dose Proportionality of Darapladib - 107038 - Follow-Up: 12-lead ECG Abnormalities

- 13/11/18 - 1 modulo, 8 itemgroups, 87 elementi, 1 linguaggio

Itemgroups: Administrative data, Record clinically significant abnormalities below., A. Rhythm, B. P-Wave Morphology, C. Conduction, D. Myocardial Infraction, E. Depolarisation/Repolarisation (QRS-T), F. Other

Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

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