A Clinical Trial to Test if the Drug OPC-108459 is Safe and Effective
Research type
Research Study
Full title
A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects with Paroxysmal and Persistent Atrial Fibrillation
IRAS ID
137906
Contact name
John Camm
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization Inc.
Eudract number
2012-005090-31
Clinicaltrials.gov Identifier
N/A
Research summary
The study drug (OPC-108459) is being evaluated as a possible treatment for rapid conversion of atrial fibrillation (AF) to sinus rhythm. AF is an irregular and often rapid heart rhythm. Sinus rhythm refers to the normal regular heartbeat.The irregular rhythm in AF, or arrhythmia, results from abnormal electrical impulses in the heart. OPC-108459 is being studied for treatment of paroxysmal and persistent atrial fibrillation. Tests taken during this study will determine how useful OPC-108459 will be in converting atrial fibrillation back to a normal rhythm.
The purpose of this study is to evaluate increased doses of the study drug to determine which doses are safe and tolerated and return the heart to sinus rhythm. This study will also measure how much study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
The trial will consist of 2 parts which will both take place in a hospital setting. Part 1 will study up to 90 patients divided into two groups: paroxysmal and persistent AF. Part 2 will evaluate 42 patients with AF: 21 with paroxysmal and 21 with persistent AF.
Part 1 will determine the best dose of the study drug and will require a single 10 min infusion of the study drug or placebo. Part 2 will test the chosen dose for safety, tolerability and effectiveness and will require an initial 10 minute infusion and then allow for a second infusion 10 minutes later if the initial infusion failed to convert AF to normal sinus rhythm.
Trial participation for each patient will be approximately 38 days, including up to a 7-day screening period, 1 dosing day with a 24-hour monitoring treatment period, and a 30-day follow-up period.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0512
Date of REC Opinion
6 Jun 2014
REC opinion
Further Information Favourable Opinion