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Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation (CADENCE 215)

This study has been terminated.
(Enrollment Difficulty)
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01483183
First received: November 29, 2011
Last updated: February 24, 2017
Last verified: February 2017
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Interventions: Drug: OPC-108459
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted in 40 participants at 10 trial sites in the following 3 countries: Germany, Spain, and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial consists of two parts (Part 1 and Part 2). Each part evaluates two populations of participants for cardioversion in a hospital setting; one diagnosed with paroxysmal atrial fibrillation (AF) and the second diagnosed with persistent AF. However, Part 2 was not conducted and therefore is not included in this document.

Reporting Groups
  Description
Paroxysmal AF - OPC-108459 0.26 mg/kg Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
Paroxysmal AF - OPC-108459 0.40 mg/kg Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Paroxysmal AF - OPC-108459 1.00 mg/kg Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Paroxysmal AF - Placebo Participants received placebo dose 10-minute constant rate IV infusion.
Persistent AF - OPC-108459 0.26 mg/kg Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 0.40 mg/kg Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 0.60 mg/kg Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 1.35 mg/kg Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 1.55 mg/kg Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - Placebo Participants received a single dose of placebo, 10-minute constant rate IV infusion.

Participant Flow:   Overall Study
    Paroxysmal AF - OPC-108459 0.26 mg/kg   Paroxysmal AF - OPC-108459 0.40 mg/kg   Paroxysmal AF - OPC-108459 1.00 mg/kg   Paroxysmal AF - Placebo   Persistent AF - OPC-108459 0.26 mg/kg   Persistent AF - OPC-108459 0.40 mg/kg   Persistent AF - OPC-108459 0.60 mg/kg   Persistent AF - OPC-108459 1.35 mg/kg   Persistent AF - OPC-108459 1.55 mg/kg   Persistent AF - Placebo
STARTED   4   1   5   3   4   4   6   4   4   5 
COMPLETED   4   1   5   3   4   4   4   4   4   4 
NOT COMPLETED   0   0   0   0   0   0   2   0   0   1 
Physician Decision                0                0                0                0                0                0                2                0                0                0 
Withdrawal by Subject                0                0                0                0                0                0                0                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paroxysmal AF - OPC-108459 0.26 mg/kg Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Paroxysmal AF - OPC-108459 0.40 mg/kg Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Paroxysmal AF - OPC-108459 1.00 mg/kg Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Paroxysmal AF - Placebo Participants had received placebo dose 10-minute constant rate IV infusion.
Persistent AF - OPC-108459 0.26 mg/kg Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 0.40 mg/kg Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 0.60 mg/kg Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 1.35 mg/kg Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - OPC-108459 1.55 mg/kg Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
Persistent AF - Placebo Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
Total Total of all reporting groups

Baseline Measures
   Paroxysmal AF - OPC-108459 0.26 mg/kg   Paroxysmal AF - OPC-108459 0.40 mg/kg   Paroxysmal AF - OPC-108459 1.00 mg/kg   Paroxysmal AF - Placebo   Persistent AF - OPC-108459 0.26 mg/kg   Persistent AF - OPC-108459 0.40 mg/kg   Persistent AF - OPC-108459 0.60 mg/kg   Persistent AF - OPC-108459 1.35 mg/kg   Persistent AF - OPC-108459 1.55 mg/kg   Persistent AF - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   1   5   3   4   4   6   4   4   5   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (19.0)   75.0  (0.0)   68.4  (9.1)   61.0  (14.1)   65.0  (5.7)   75.0  (10.1)   63.5  (14.7)   64.8  (12.9)   64.3  (7.7)   70.4  (8.8)   66.6  (11.75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                     
Female      1  25.0%      1 100.0%      3  60.0%      1  33.3%      1  25.0%      1  25.0%      1  16.7%      0   0.0%      1  25.0%      1  20.0%      11  27.5% 
Male      3  75.0%      0   0.0%      2  40.0%      2  66.7%      3  75.0%      3  75.0%      5  83.3%      4 100.0%      3  75.0%      4  80.0%      29  72.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Maximum (Peak) Plasma Concentration (Cmax)   [ Time Frame: 24 hours ]

2.  Primary:   Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)   [ Time Frame: 24 hours ]

3.  Primary:   Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion   [ Time Frame: 24 hours ]

4.  Primary:   Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion   [ Time Frame: 24 hours ]

5.  Primary:   Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion   [ Time Frame: 24 hours ]

6.  Secondary:   Part 1: Percentage of Participants With NSR   [ Time Frame: 30 minutes ]

7.  Primary:   Part 2/1 Infusion: Cmax   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Primary:   Part 2/2 Infusions: Cmax   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Primary:   Part 2/1 Infusion: AUCt   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Primary:   Part 2/2 Infusions: AUCt   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Primary:   Part 2: QTcF   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Primary:   Part 2: Ventricular Rate   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Primary:   Part 2: Diastolic and Systolic Blood Pressure   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Primary:   Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Secondary:   Part 2: Time to NSR   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Secondary:   Part 2: Duration of NSR   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Secondary:   Part 2: Duration of NSR   [ Time Frame: 168 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was terminated after Part 1 enrollment completed. It did not progress due to many factors including slow enrollment, limited site activity in pre-screening, absence of reproducible efficacy signal and increased costs.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974



Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01483183     History of Changes
Other Study ID Numbers: 269-11-215
Study First Received: November 29, 2011
Results First Received: October 4, 2016
Last Updated: February 24, 2017