Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-194715 | Other Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-61815 injection | Experimental | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-61815 injection | Drug | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | "An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an AE that leads to death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient or prolonged hospitalization, results in a congenital anomaly/birth defect, or any other important medical event which is medically significant. A TEAE is an AE that occurs only after a subject has received IMP. | From the start of IMP administration (Day 1) up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change in body weight from baseline (before IMP administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement. | Baseline, Day after final IMP administration |
| Improvement Rate for Lower Limb Edema |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gifu Prefectural General Medical Center | Gifu | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 45 subjects were administered investigational medicinal product (IMP): 38 subjects with dose maintained at 8 mg, and 7 subjects with dose increased to 16 mg. None of the subjects reduced the dose after the dose was increased to 16 mg. All 45 subjects received at least one dose of IMP and thus were included in the safety analysis set. Overall, 41 subjects completed the trial (34 of those subjects completed the trial early), and 4 subjects were discontinued from the trial.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OPC-61815 Injection | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: subjects who received at least one dose of IMP
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OPC-61815 Injection | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | "An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an AE that leads to death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient or prolonged hospitalization, results in a congenital anomaly/birth defect, or any other important medical event which is medically significant. A TEAE is an AE that occurs only after a subject has received IMP. | Safety Analysis Set: subjects who received at least one dose of IMP | Posted | Number | percentage of participants | From the start of IMP administration (Day 1) up to 15 days |
|
TEAEs were collected from the start of IMP administration up to 15 days
Subjects who received at least one dose of IMP were included in the safety analysis.
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 | OPC-61815 Injection Maintained at 8 mg | Intravenous administration of OPC-61815 at 8 mg once daily for a maximum of 5 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2020 | Jul 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2020 | Jul 15, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
|
| Baseline, Day after final IMP administration |
| Improvement Rate for Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Baseline, Day after final IMP administration |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Body Weight | Change in body weight from baseline (before IMP administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement. | Subjects with both baseline and evaluation of the given parameter at the specific visit. | Posted | Mean | 95% Confidence Interval | kg | Baseline, Day after final IMP administration |
|
|
|
| Secondary | Improvement Rate for Lower Limb Edema | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Efficacy Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline dose efficacy measurement. "Overall Number of Participants Analyzed" = number of subjects with baseline symptoms. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day after final IMP administration |
|
|
|
| Secondary | Improvement Rate for Pulmonary Congestion | The improvement rate was defined as the percentage of subjects in whom a symptom was present at baseline and then markedly improved or improved after IMP administration. Improvement category is a 4-point scale below:
| Efficacy Analysis Set: subjects who received at least one dose of IMP and had at least one postbaseline dose efficacy measurement. "Overall Number of Participants Analyzed" = number of subjects with baseline symptoms. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day after final IMP administration |
|
|
|
| 0 |
| 38 |
| 2 |
| 38 |
| 22 |
| 38 |
| EG001 | OPC-61815 Injection Increased to 16 mg | Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8 mg, increase the dose to 16 mg on Day 2 and onward, according to the dose escalation criteria. | 0 | 7 | 0 | 7 | 2 | 7 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA Ver. 23.0 | Non-systematic Assessment |
|
Not provided
Not provided