Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing

- 18.03.20 - 1 Formular, 9 Itemgruppen, 44 Datenelemente, 1 Sprache

Itemgruppen: Biomarker Samples, Pharmacogenetic Research Consent/ Blood Sample Collection, Transcriptomic Research Sample Collection Details, PK Blood Sample - Before Infusion, PK Blood Sample - End of Infusion, PK Type Code, Vital Signs, Investigational Product - IV Dosing, Total Volume of Infusion unit

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Subject Logs - Medical/ Surgical Procedures; Expanded/ Additional Pharmacogenetic Research Consent and Withdrawal

- 24.02.20 - 1 Formular, 3 Itemgruppen, 20 Datenelemente, 1 Sprache

Itemgruppen: Medical/ Surgical Procedures, Expanded/ Additional Pharmacogenetic Research Consent, Expanded/ Additional Pharmacogenetic Research Withdrawal

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - IP Compliance; Pharmacogenetic (PGx) Research

- 09.01.20 - 1 Formular, 6 Itemgruppen, 30 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Investigational Product - Study drug dispensed, Additional bottle(s) dispensed, Current investigational product level, L-Dopa medication, Pharmacogenetic Research

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - PGx

- 27.12.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)

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

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Pharmacogenetic (PGx) Research

- 17.12.19 - 1 Formular, 5 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy 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: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - PGx - Pharmacogenetic Research

- 08.12.19 - 1 Formular, 5 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Withdraw, Pharmacogenetic Test, Blood specimen, Destruction

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

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent Withdrawal

- 14.11.19 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Withdrawal of consent for Pharmacogenetic Research, DNA sample destruction

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record whether consent for PGx Pharmacogenetic Research has been withdrawn, and whether the sample was requested to be destroyed.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent

- 14.11.19 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Pharmacogenetic research consent

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record whether and when Informed Consent has been obtained for PGx Pharmacogenetic Research.

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - PGx-Pharmacogenetic Research Consent

- 06.11.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw

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

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Pharmacogenetic research consent and withdrawal of consent

- 04.11.19 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, PGx - Pharmacogenetic research consent, Pharmacogenetic research withdrawal of consent

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Pharmacogenetic research consent and withdrawal of consent form.

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

- 31.10.19 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Investigational Product; Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medication; Non-Serious Adverse Events; Serious Adverse Events

- 30.10.19 - 1 Formular, 24 Itemgruppen, 92 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Investigational Product, Status of Treatment Blind, Consent for Pharmacogenetic Research, PGx - Blood Sample Collection (DNA), PGx - Withdrawal of Consent, PGx - Blood Sample Destruction, Concomitant Medications, Concomitant Medications , Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Events, Serious Adverse Events - Section 1, Serious Adverse Events - Section 2 (Seriousness), Serious Adverse Events - Section 3 (Demography Data), Serious Adverse Events - Section 4, Serious Adverse Events - Section 5 (Possible Cause of SAE), Serious Adverse Events - Medical Conditions, Serious Adverse Events - Section 7 (Other relevant Risk Factors), Serious Adverse Events - Section 8 (Relevant Concomitant Medication), Serious Adverse Events - Section 9 (Details of Investigational Product(s)), Serious Adverse Events - Section 10 ( Details of relevant Assessments), Serious Adverse Events - Section 11 (Narrative Remarks), Serious Adverse Events - Investigator's signature

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 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

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