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Enrollment Difficulty
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The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.
This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.
The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.
Cohorts of paroxysmal and persistent subjects may have their dose increased independently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent or Paroxysmal AF Part 1: OPC-108459 | Experimental | To safely meet each of the following Cmax targets: 1.0-10.0 µg/mL. There will be 9 cohorts in all: 1.0, 1.6, 2.4, 3.6, 5.4, 7.0, 8.0, 9.0, and 10.0. |
|
| Persistent or Paroxysmal AF Part 1: Placebo | Placebo Comparator |
| |
| Persistent or Paroxysmal AF Part 2: OPC-108459 | Experimental | Single dose to safely meet target concentration from Part 1, if subject fails to convert to sinus rhythm within 10 minutes, second dose will be administered to achieve 25% increase when compared to first infusion |
|
| Placebo Part 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-108459 | Drug | Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum (Peak) Plasma Concentration (Cmax) | OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion. | 24 hours |
| Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ) | OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion. | 24 hours |
| Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion | 12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection. | 24 hours |
| Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion | 12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection. | 24 hours |
| Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion | Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With NSR | Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion. | 30 minutes |
| Part 2: Time to NSR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects with:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otsuka Investigational Site | Washington D.C. | District of Columbia | 20422 | United States | ||
| Otsuka Investigational Site |
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.
This trial was conducted in 40 participants at 10 trial sites in the following 3 countries: Germany, Spain, and the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Paroxysmal AF - OPC-108459 0.40 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
|
| Placebo | Drug | Placebo dose, 10-minute constant rate IV infusion |
|
| 24 hours |
| Part 2/1 Infusion: Cmax | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2/2 Infusions: Cmax | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2/1 Infusion: AUCt | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2/2 Infusions: AUCt | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2: QTcF | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2: Ventricular Rate | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2: Diastolic and Systolic Blood Pressure | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR) | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
| 24 hours |
| Part 2: Duration of NSR | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 24 hours |
| Part 2: Duration of NSR | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | 168 hours |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Otsuka Investigational Site | Jacksonville | Florida | 32209 | United States |
| Otsuka Investigational Site | Sarasota | Florida | 34232 | United States |
| Otsuka Investigational Site | Lexington | Kentucky | 40536 | United States |
| Otsuka Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Otsuka Investigational Site | Johnson City | New York | 13790 | United States |
| Otsuka Investigational Site | Germantown | Tennessee | 38138 | United States |
| Otsuka Investigational Site | Houston | Texas | 77024 | United States |
| Otsuka Investigational Site | Berlin | 13953 | Germany |
| Otsuka Investigational Site | Hamburg | 22291 | Germany |
| Otsuka Investigational Site | Leipzig | 04289 | Germany |
| Otsuka Investigational Site | Pirna | 01796 | Germany |
| Otsuka Investigational Site | San Fermo | Como | 22100 | Italy |
| Otsuka Investigational Site | Ancona | 60126 | Italy |
| Otsuka Investigational Site | Bologna | 40138 | Italy |
| Otsuka Investigational Site | Cremona | 26100 | Italy |
| Otsuka Investigational Site | Amsterdam | 1105AZ | Netherlands |
| Otsuka Investigational Site | Groningen | 9713GZ | Netherlands |
| Otsuka Investigational Site | Fuenlabrada | Madrid | 28942 | Spain |
| Otsuka Investigational Site | Barcelona | 08970 | Spain |
| Otsuka Investigational Site | Granada | 18014 | Spain |
| Otsuka Investigational Site | Madrid | 28034 | Spain |
| Otsuka Investigational Site | Madrid | 28905 | Spain |
| Otsuka Investigational Site | Chertsey | Surrey | KT160PZ | United Kingdom |
Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target. |
| FG002 | 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. |
| FG003 | Paroxysmal AF - Placebo | Participants received placebo dose 10-minute constant rate IV infusion. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | Persistent AF - Placebo | Participants received a single dose of placebo, 10-minute constant rate IV infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Paroxysmal AF - Placebo | Participants had received placebo dose 10-minute constant rate IV infusion. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Maximum (Peak) Plasma Concentration (Cmax) | OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion. | PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion. | Posted | Mean | Standard Deviation | μg/mL | 24 hours |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ) | OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion. | PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion. | Posted | Mean | Standard Deviation | μg∙h/mL | 24 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion | 12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection. | Safety dataset included all participants who had received at least one dose of the trial medication. | Posted | Mean | Standard Deviation | msec | 24 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion | 12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection. | Safety dataset included all participants who had received at least one dose of the trial medication. | Posted | Mean | Standard Deviation | beats/minute | 24 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion | Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours. | Safety dataset included all participants who had received at least one dose of the trial medication. | Posted | Mean | Standard Deviation | mmHg | 24 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2/1 Infusion: Cmax | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2/2 Infusions: Cmax | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2/1 Infusion: AUCt | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2/2 Infusions: AUCt | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: QTcF | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Ventricular Rate | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Diastolic and Systolic Blood Pressure | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR) | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Percentage of Participants With NSR | Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion. | Safety dataset included all participants who had received at least one dose of the trial medication. | Posted | Number | percentage of participants | 30 minutes |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Time to NSR | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Duration of NSR | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Duration of NSR | The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document. | Not Posted | 168 hours | Participants |
Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 4 | 1 | 4 | ||
| EG001 | 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. | 0 | 1 | 1 | 1 | ||
| EG002 | 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. | 0 | 5 | 2 | 5 | ||
| EG003 | Paroxysmal AF - Placebo | Participants had received placebo dose 10-minute constant rate IV infusion. | 1 | 3 | 0 | 3 | ||
| EG004 | 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. | 0 | 4 | 0 | 4 | ||
| EG005 | 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. | 0 | 4 | 1 | 4 | ||
| EG006 | 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. | 0 | 4 | 0 | 4 | ||
| EG007 | 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. | 0 | 4 | 1 | 4 | ||
| EG008 | 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. | 0 | 4 | 1 | 4 | ||
| EG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
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.
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 from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| OG003 | Paroxysmal AF - Placebo | Participants had received placebo dose 10-minute constant rate IV infusion. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. |
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| OG003 | Paroxysmal AF - Placebo | Participants had received placebo dose 10-minute constant rate IV infusion. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. |
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| OG003 | Paroxysmal AF - Placebo | Participants had received placebo dose 10-minute constant rate IV infusion. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. |
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| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | Persistent AF - Placebo | Participants had received a single dose of placebo, 10-minute constant rate IV infusion. |
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