Phase 3
N=294
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03772041 ↗Enrolled (actual)
294
Serious AEs
3.7%
Results posted
Aug 2021
Primary outcome: Primary: Change From Baseline in Body Weight — -1.67; -1.36 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OPC-61815 (Drug); Tolvaptan Tab 15 MG (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight |
-1.67; -1.36 | — |
| SECONDARY Improvement Rate for Lower Limb Edema and Pulmonary Congestion |
68.9; 75.7; 56.1; 64.7 | — |
| SECONDARY Change From Baseline in Jugular Venous Distension and Hepatomegaly |
-2.89; -3.15; -0.93; -0.88 | — |
| SECONDARY Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound |
74.3; 78.9; 31.7; 31.0 | — |
| SECONDARY Improvement Rate for New York Heart Association (NYHA) Classification |
44.9; 42.5 | — |
Summary
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists
Eligibility Criteria
Inclusion Criteria
- Patients 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
- Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- Patients who are currently hospitalized or who are able to be hospitalized during the trial
Exclusion Criteria
- Patients with acute heart failure
- Patients who are on a ventricular assist device
- Patients who are unable to sense thirst or who have difficulty with fluid intake
Data sourced from ClinicalTrials.gov (NCT03772041). 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.