N/A
Completed N=61
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Source: ClinicalTrials.gov NCT03254108 ↗Enrolled (actual)
61
Serious AEs
1.7%
Results posted
Jul 2021
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 — 41.4; 98.6; 149; 282 ng/mL
Summary
The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1 |
41.4; 98.6; 149; 282; 325 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1 |
356; 983; 1340; 2400; 2850 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are currently on treatment with any of the following diuretics
- Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
- Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
- Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
- Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Subjects who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion Criteria
- Subjects with acute heart failure
- Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
- Subjects who are unable to sense thirst or who have difficulty with fluid intake
Data sourced from ClinicalTrials.gov (NCT03254108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.