Phase 2
N=157
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Cardiac Edema (CHF)
Bottom Line
View on ClinicalTrials.gov: NCT05615363 ↗Enrolled (actual)
157
Serious AEs
2.6%
Results posted
Oct 2025
Primary outcome: Primary: Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8 — -1.96; -1.74; -1.4; -1.84 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OPC 131461 10mg group (Drug); OPC 131461 5mg group (Drug); OPC 131461 2mg group (Drug); OPC 131461 1mg group (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 8 |
-1.96; -1.74; -1.4; -1.84; -1.17 | — |
| SECONDARY Change in Body Weight From Baseline to Last Assessment Time Point (the Day After IMP Administration) by Day 15 |
-2.12; -2.11; -1.72; -1.87; -1.38 | — |
| SECONDARY Improvement of or Change in Congestive Findings ( Lower Limb Edema ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7 |
16; 18; 9; 19; 19 | — |
| SECONDARY Improvement of or Change in Congestive Findings ( Pulmonary Congestion ) From Baseline to Last Assessment Time Point (the Day of IMP Administration) by Day 7 |
21; 19; 10; 22; 18 | — |
Summary
To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists
Eligibility Criteria
Inclusion Criteria
- Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
- Subjects undergoing any of the following diuretic therapies
- Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
- Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
- Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
- Subjects who were currently hospitalized or who are able to be hospitalized
Exclusion Criteria
- Subjects with acute heart failure
- Subjects with an assisted circulation device
- Subjects who cannot sense thirst or who have difficulty in ingesting water
Data sourced from ClinicalTrials.gov (NCT05615363). 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.