Trial Profile

Double blind randomized controlled trial of budiodarone versus placebo in subjects with symptomatic non-permanent AF and LEAF lasting longer than 5.5 hours.

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 04 Mar 2024

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

04 Mar 2024 New trial record
26 Feb 2024 According to an XYRA media release, the company announced the successful completion of End of phase II meeting with the US FDA for the agreement of endpoint of the trial which will support the approval of Budiodarone for the treatment of symptomatic atrial fibrillation.
26 Feb 2024 According to According to an XYRA media release, if the drug continues to be safe and effective in the agreed AF pivotal studies above and a short-term study of ventricular tachycardia (VT) subjects with an implantable cardiac defibrillator (ICD), then approval may be possible within International Conference on Harmonization (ICH) guidance.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com