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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 4, Cohort 2 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 30.12.20 - 1 Formular, 20 Itemgruppen, 72 Datenelemente, 1 Sprache

Itemgruppen: Date of visit, Investigational Product (Dose) (Part 2 Period 4) , ECG (Part 2 Period 4) , ECG (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Vital Signs (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Pulmonary Function Tests (Part 2 Period 4) , Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Blood (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Pharmacokinetics Urine (Part 2 Period 4) , Summary Holter (Part 2 Period 4) , Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours), Holter Abnormalities (Part 2 Period 4) , Holter Abnormalities (Part 2 Period 4)

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 5, Cohort 2: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics; SUmmary Holter; Holter Abnormalities; Pulmonary Function Tests

- 30.12.20 - 1 Formular, 21 Itemgruppen, 84 Datenelemente, 1 Sprache

Itemgruppen: Date of Visit, Local Laboratory - Haematology (Period 5), Local Laboratory - Haematology (Period 5), Local Laboratory - Clinical Chemistry (Period 5), Local Laboratory - Clinical Chemistry (Period 5), Investigational Product (Dose) (Period 5), ECG (Period 5), Vital Signs (Period 5), Local Laboratory - Haematology (24Hr Lab) (Period 5), Local Laboratory - Haematology (24 Hr Lab) (Period 5), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 5), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 5), Pharmacokinetics Blood (Period 5), Pharmacokinetics Blood (Period 5), Pharmacokinetics Urine (Period 5), Pharmacokinetics Urine (Period 5), Summary Holter (Period 5), Summary Holter (Period 5) (Pre-Dose - 24 hours) , Holter Abnormalities (Period 5), Holter Abnormalities (Period 5), Pulmonary Function Tests (Period 5)

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 2, Period 6, Cohort 2 Day 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 30.12.20 - 1 Formular, 20 Itemgruppen, 72 Datenelemente, 1 Sprache

Itemgruppen: Date of visit, Investigational Product (Dose) (Period 6), ECG (Period 6), ECG (Period 6), Vital Signs (Period 6), Vital Signs (Period 6), Pulmonary Function Tests (Period 6), Pulmonary Function Tests (Period 6), Local Laboratory - Haematology (24Hr Lab) (Period 6) , Local Laboratory - Haematology (24 Hr Lab) (Period 6), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 6), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 6) , Pharmacokinetics Blood (Period 6), Pharmacokinetics Blood (Period 6), Pharmacokinetics Urine (Period 6), Pharmacokinetics Urine (Period 6), Summary Holter (Period 6), Summary Holter (Period 6) (Pre-Dose - 24 hours), Holter Abnormalities, Holter Abnormalities

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 4, Day 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities

- 29.12.20 - 1 Formular, 20 Itemgruppen, 72 Datenelemente, 1 Sprache

Itemgruppen: Date of visit, Investigational Product (Dose) (Period 4) , ECG (Period 4), ECG (Period 4) , Vital Signs (Period 4), Vital Signs (Period 4) , Pulmonary Function Tests (Period 4), Pulmonary Function Tests (Period 4) , Local Laboratory - Haematology (24Hr Lab) (Period 4) , Local Laboratory - Haematology (24 Hr Lab) (Period 4), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 4) , Pharmacokinetics Blood (Period 4), Pharmacokinetics Blood (Period 4) , Pharmacokinetics Urine (Period 4), Pharmacokinetics Urine (Period 4), Summary Holter (Period 4), Summary Holter (Period 4) (Pre-Dose - 24 hours), Holter Abnormalities, Holter Abnormalities

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Part 1, Period 1 - 3: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics

- 22.12.20 - 1 Formular, 17 Itemgruppen, 61 Datenelemente, 1 Sprache

Itemgruppen: Date of Visit, Local Laboratory - Haematology (Period 1 - 3), Local Laboratory - Haematology (Period 1 - 3), Local Laboratory - Clinical Chemistry (Period 1 - 3), Local Laboratory - Clinical Chemistry (Period 1 - 3), Investigational Product (Dose) (Period 1 - 3), ECG (Period 1 - 3), Vital Signs (Period 1 - 3), Pulmonary Function Tests (Period 1 - 3), Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3), Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3) , Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3), Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3) , Pharmacokinetics Blood (Period 1 - 3), Pharmacokinetics Blood (Period 1 - 3), Pharmacokinetics Urine (Period 1 - 3), Pharmacokinetics Urine (Period 1 - 3)

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacokinetics

- 18.12.20 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Dosing date and time, Pharmacokinetics Blood

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the P1 D1 and P2 D1 Visit.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities

- 13.12.20 - 1 Formular, 6 Itemgruppen, 37 Datenelemente, 1 Sprache

Itemgruppen: Pharmacokinetics Blood, Pulmonary Function Tests, Local Laboratory, Summary Holter, Holter Abnormalities, Holter Abnormalities

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

- 29.11.20 - 1 Formular, 8 Itemgruppen, 42 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Vital Signs (sitting) - Day 1 - 5, Study Drug Administration (80 mg Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 1, Pharmacokinetic Blood Collection (Simvastatin) - Day 2 , Pharmacokinetic Blood Collection (Simvastatin) - Day 3, Pharmacokinetic Blood Collection (Simvastatin) - Day 4, Pharmacokinetic Blood Collection (Simvastatin) - Day 5

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 7 - 35: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Albiglutide), Electrocardiogram

- 29.11.20 - 1 Formular, 5 Itemgruppen, 35 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Vital Signs (sitting) - Day 7 - 35, Study Drug Administration (50 mg Albiglutide) - Day 7 - 35, Pharmacokinetic Blood Collection (Albiglutide) - Day 35, Electrocardiogram (Day 14)

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory

- 29.11.20 - 1 Formular, 13 Itemgruppen, 72 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Vital Signs (sitting) - Day 37 - 42, Follow up, Electrocardiogram (Day 37), Central Laboratory - Haematology (Day 37), Central Laboratory - Chemistry (Day 37), Central Laboratory - UA/UDS/Urine HCG/ Urine Chem (Day 37), Study Drug Administration (80 mg Simvastatin) - Day 38, Pharmacokinetic Blood Collection (Simvastatin) - Day 38, Pharmacokinetic Blood Collection (Albiglutide) - Day 38, Pharmacokinetic Blood Collection (Simvastatin) - Day 39, Pharmacokinetic Blood Collection (Simvastatin) - Day 40, Pharmacokinetic Blood Collection (Simvastatin) - Day 41, Pharmacokinetic Blood Collection (Simvastatin) - Day 42

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

- 14.09.20 - 1 Formular, 4 Itemgruppen, 42 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Anticoagulation therapy taken prior to study, Pharmacokinetic sample, heparin induced thrombocytopenia testing, Argatroban Indication

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in at the screening visit. Section Pre-Treatment Anticoagulation has to be filled in within 96 hours prior to treatment initiation and additionally, if Heparin was administered, ACT or aPTT have to be measured before Heparin administration. Section Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use has to be filled in within 96 hours before treatment initiation administration. Section Indication for Argatroban Use records the indications on behalf of which is the medicament administered.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

- 03.09.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in whether such samples are drawn during the Study Period. Study Protocol specifies when such Samples should be drawn.

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