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To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | OPC-41061 |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-41061(Tolvaptan) | Drug | Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | The body weight change from baseline at the time of final trial drug administration | Baseline, at the time of final trial drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-41061 7.5 mg | OPC-41061 7.5 mg/day |
| FG001 | OPC-41061 15 mg | OPC-41061 1.5 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-41061 7.5 mg | OPC-41061 7.5 mg/day |
| BG001 | OPC-41061 15 mg | OPC-41061 15 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Body Weight | The body weight change from baseline at the time of final trial drug administration | Posted | Mean | Standard Deviation | Kg | Baseline, at the time of final trial drug administration |
|
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-41061 7.5 mg | OPC-41061 7.5 mg/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | MedDRA (11.0)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7314 |
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| ID | Term |
|---|---|
| D004489 | Edema, Cardiac |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D004487 | Edema |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Subjects will be orally administered placebo once daily after breakfast for seven days. |
|
| Kyushu Region |
| Japan |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | OPC-41061 15 mg | OPC-41061 15 mg/day | 1 | 10 | 9 | 10 |
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Urea Increased | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Uric Acid Increased | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Blood Urine Present | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Faecal Occult Blood | Investigations | MedDRA (11.0)J | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Altered State of Consciousness | Nervous system disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Oedema Genital | Reproductive system and breast disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Genital Haemorrhage | Reproductive system and breast disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Dematitis Contact | Skin and subcutaneous tissue disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
| Wound Haemorrhage | Vascular disorders | MedDRA (11.0)J | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |