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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Pregnancy Notification Form

- 2019-01-11 - 1 Formulär, 7 Item-grupper, 46 Dataelement, 1 Språk
Item-grupper: Administrative data, Pregnancy Notification Form (Subject), Mother's Relevant Medical/Family History, If applicable, record the number in the appropriate categories below:, Father's Relevant Medical/Family History, Drug Exposures, Reporting Investigator Information
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Pharmacogenetics Research Consent Form

- 2019-01-11 - 1 Formulär, 3 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Administrative data, Date of Visit/Assessment, PGx Research Consent
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Pharmacogenetics Research Consent Withdrawal

- 2019-01-11 - 1 Formulär, 3 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Administrative data, Date of Visit/Assessment, PGx Research Withdrawal of Consent
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Pharmacokinetics RPT

- 2019-01-11 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Administrative data, PK RPT Data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: 12-lead ECG Abnormalities

- 2019-01-11 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: Administrative data, 12-lead ECG Abnormalities, Record clinically significant abnormalities below. Check all that apply:
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Vital Signs Form

- 2019-01-11 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative data, Vital Signs
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Adverse Event

- 2019-01-11 - 1 Formulär, 2 Item-grupper, 21 Dataelement, 1 Språk
Item-grupper: Administrative data, Adverse Events
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Concomitant Medications

- 2019-01-11 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Administrative data, Concomitant Medications
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: Adverse Event and Concomitant Medication Questions

- 2019-01-11 - 1 Formulär, 3 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Administrative data, Date of Visit/Assessment, Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Follow-Up: Pregnancy Information

- 2019-01-11 - 1 Formulär, 3 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Administrative data, Pregnancy Information, Pregnancy Information Part 2
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Follow-Up: Study Conclusion

- 2019-01-11 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative data, Study Conclusion Data
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: 12-lead ECG Form

- 2019-01-09 - 1 Formulär, 3 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Administrative data, Dosing date and time, 12- Lead ECG
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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