At a glance
ClinicalIndex Comparison Record- ✓Currently on loop diuretics at ≥40 mg/day furosemide equivalent, or concomitant loop diuretic with thiazide diuretic, or concomitant loop diuretic with aldosterone antagonist/potassium-sparing diuretic
- ✓Congestive heart failure with evidence of volume overload: lower limb edema, pulmonary congestion, and/or jugular venous distension
- ✓Currently hospitalized or able to be hospitalized during the trial
- ✕Acute heart failure
- ✕Hypersensitivity to OPC-61815 or tolvaptan or their ingredients
- ✕Unable to sense thirst or difficulty with fluid intake
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
In Brief
A clinical study evaluating OPC-61815 injection 2mg, OPC-61815 injection 4mg, and 3 other interventions for Congestive Heart Failure. Completed, enrolled 61 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.