ID
41355
Description
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 during the Treatment period whenever an Infusion of Argatroban is administered. Circuit Prime and Bolus Infusions are recorded in a separate form.
Lien
https://clinicaltrials.gov/ct2/show/NCT00039858
Mots-clés
Versions (1)
- 03/09/2020 03/09/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 septembre 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Dosing Information - Infusion
- StudyEvent: ODM
Description
Dosing Information - Infusion
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C0574032
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0808070
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1301880
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0806020
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1522314
Description
Infusion dose
Type de données
float
Unités de mesure
- mcg/kg/min
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0178602
Description
Infusion rate
Type de données
float
Unités de mesure
- mL/hr
Alias
- UMLS CUI [1]
- C2964135
Similar models
Dosing Information - Infusion
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0574032 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])