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131 Suchergebnisse.

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

- 18.02.19 - 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

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Week 10 - Vital Signs Pre-Dose; Subject's Food Intake; Investigational Product; Vital Signs - Post-Dose

- 18.02.19 - 1 Formular, 6 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Vital Signs - Pre-Dose, Subject's Food Intake, Investigational Product, Vital Signs - 2 Hours Post-Dose, Vital Signs - 4 Hours Post-Dose
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 Collaborators: N/A 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

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Baseline - Vital Signs Pre-Dose; Subject's Food Intake; 12-Lead-ECG - Pre-Dose; Randomisation Number; Investigational Product; Vital Signs - Post-Dose

- 12.02.19 - 1 Formular, 8 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Vital Signs - Pre-Dose, Subject's Food Intake, 12-Lead ECG - Pre-Dose, Randomisation Number, Investigational Product, Vital Signs - 2 Hours Post-Dose, Vital Signs - 4 Hours Post-Dose
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 Collaborators: N/A 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

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Investigational Product Use/Status of Treatment Blind

- 25.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Investigational Product Use, Status Of Treatment Blind
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Repeat Dose Phase Day 26 - Investigational Product/Treatment Confirmation

- 19.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Repeat Dose Phase Day 25 - Investigational Product/Treatment Confirmation

- 19.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride – 106218 - Part 2: Repeat Dosing Phase - Day 26 - Pharmacokinetics (Blood)

- 17.01.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Pharmacokinetic aspects; Blood, Pharmacokinetic aspects, Blood, Dutasteride
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride – 106218 - Part 2: Repeat Dose Phase - Day 25 - Pharmacokinetics (Blood)

- 17.01.19 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Pharmacokinetic aspects; Blood, Trough, Pharmacokinetic aspects, Blood, Dutasteride
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Treatment Period - Day 18 - Investigational Product/Treatment Confirmation

- 17.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Repeat Dose Phase Day 24 - Investigational Product/Treatment Confirmation

- 14.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Repeat Dose Phase Day 23 - Investigational Product/Treatment Confirmation

- 14.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Repeat Dose Phase Day 22 - Investigational Product/Treatment Confirmation

- 14.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male