Eudra-clinical trial number

We thank you very much for your patience and we apologise for the inconvenience. The release notes for EudraCT version number The statistics for September are now available. Sponsors of trials that are "prematurely ended" can now post results in EudraCT as a pdf document. Please refer to the Tutorials on posting results in order to know how to become a primary user for your trial and post the pdf document.

After the document has been uploaded, kindly click on "post results" on the top right corner. The document will be published in EU CTR after 2 weeks from posting date except for phase 1 trials in adults, that are not publicly available, see FAQs.

A new version of the document " Results: modalities and timing of posting " is now available. This document provides more clarity regarding the modality of results posting for trials ended before 21 July and between 21 July and 21 July Computer application maintenance weekend September Essential maintenance work will be carried out to all EMA Telematics applications.

As a result, the EudraCT website will be unavailable to users between hrs on Friday, 18th September and hrs on Monday, 21th September As a result, EudraCT systems will be intermittently unavailable between hrs and hrs of Saturday, 11 July The frequently asked questions have been updated.

Previous news can be found here. AE includes serious as well as Non-serious AEs. Analysis done on Safety Set SS included all randomized subjects who received any amount of study drug.

Subjects were analyzed as per actual treatment received. Any AE that increased in severity or newly developed at or after the initial dosing of study drug to 28 days after the last dose is TEAE.

Ctrough, Ctrough,avg, Ch, and Ch,avg for lumacaftor, M28 lumacaftor lumacaftor metabolite , ivacaftor, M1 ivacaftor ivacaftor metabolite , and M6 ivacaftor ivacaftor metabolite were calculated.

Ch,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and This endpoint was not planned to be assessed in Placebo arm. Analysis was performed on Pharmacokinetic PK population included all randomized subjects who received at least one dose of study drug and had a PK assessment. For Ch: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For Ch,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and Other adverse events includes only non-serious AEs.

Serious adverse events. Non-serious adverse events. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Trial information. Top of page. Vertex Pharmaceuticals Incorporated. Is trial part of an agreed paediatric investigation plan PIP.

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