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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

- 29/04/2022 - 1 Formular, 6 Itemgruppen, 47 Datenelemente, 1 Sprache
Itemgruppen: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 28, Pre-dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 1, Pre-dose

- 13/04/2022 - 1 Formular, 6 Itemgruppen, 47 Datenelemente, 2 Sprachen
Itemgruppen: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 1, Pre-Dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

- 06/04/2022 - 1 Formular, 3 Itemgruppen, 35 Datenelemente, 1 Sprache
Itemgruppen: Pregnancy Test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 14, Pre-dose.

Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 01/04/2022 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Hematology, Biochemistry, Pregnancy Tests
Sponsor: OSI Pharmaceuticals Information provided by : Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Baseline Local Laboratory Data

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 18/11/2021 - 9 Formulare, 1 Itemgruppe, 3 Datenelemente, 1 Sprache
Itemgruppe: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Itemgruppen 84 Datenelemente

On-Treatment 2

13 Itemgruppen 62 Datenelemente

On-Treatment 4

12 Itemgruppen 62 Datenelemente

On-Treatment 6

12 Itemgruppen 62 Datenelemente

On-Treatment 7

13 Itemgruppen 67 Datenelemente

On-Treatment 8

13 Itemgruppen 67 Datenelemente

Study completion_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Study completion form

- 27/09/2021 - 1 Formular, 5 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Study completion, Hematology, Biochemistry, Withdrawal of demand medication, Assessment
Study part: Study completion form.Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20/09/2021 - 1 Formular, 10 Itemgruppen, 61 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria, Demographics, Medical history, Parkinson's disease Surgical history, Allergies, Parkinson's disease history, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test
Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Riliva_CRF_EudraCT - Nr. 2012-000108-13- Screening DRKS00004652 - Screening II

- 17/09/2021 - 2 Formulare, 4 Itemgruppen, 41 Datenelemente, 2 Sprachen
Itemgruppen: Basic data, Inclusion Criteria, Exclusion Criteria, Urine pregnancy test
Study documentation part: Screening. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Screening I

4 Itemgruppen 44 Datenelemente

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 15/02/2021 - 1 Formular, 15 Itemgruppen, 54 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Day -1 - Pregnancy Test; Urine Test for Drugs of Abuse; Carbon Monoxide Test

- 19/01/2021 - 1 Formular, 5 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Pregnancy Test, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Carbon Monoxide Test
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

- 20/05/2020 - 1 Formular, 9 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Significant Medical/ Surgical History (Period 1 Day -1), Significant Medical/ Surgical History (Period 2 Day -1), Significant Medical/ Surgical History , Physical Examination (Period 1 Day -1), Physical Examination (Period 2 Day -1), Physical Examination (Follow-Up) , Physical Examination - Investigator's Signature, Pregnancy Test (Females only)
Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Pregnancy Test

- 05/05/2020 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Pregnancy Test
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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