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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06021860). This is a study registration, not published results. Lead sponsor: CMP Development, LLC. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 96 participants (ESTIMATED). Conditions: Edema Due to Heart Failure or Cirrhosis. Interventions: DRUG: Spironolactone Oral Suspension. Primary outcome measures: Part 1: Absorption rate constant (Ka) of spironolactone (time^-1) in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 2: Absorption rate constant (Ka) of spironolactone (time^-1) in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 1: Total clearance from plasma after oral administration (CL/F) of spironolactone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 2: Total clearance from plasma after oral administration (CL/F) of spironolactone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 1: Volume of distribution after oral administration (V/F) of spironolactone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 2: Volume of distribution after oral administration (V/F) of spironolactone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 1: Total clearance from plasma after oral administration (CL/F) of canrenone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 2: Total clearance from plasma after oral administration (CL/F) of canrenone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 1: Volume of distribution after oral administration (V/F) of canrenone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 2: Volume of distribution after oral administration (V/F) of canrenone in the multiple-dose period , Pre-dose (Day 1) to 22-26 hours post-dose (Day 11); Part 1: Change from baseline in body weight (kg) (Groups 1 through 3) , Day 1 to Day 18; Part 1: Change from baseline in body weight (kg) (Group 4) , Day 1 to Day 26; Part 2: Change from baseline in body weight (kg) (Groups 1 through 3) , Day 1 to Day 18; Part 2: Change from baseline in body weight (kg) (Group 4) , Day 1 to Day 26; Part 1: Change from baseline in sodium/potassium (Na/K) ratio (Groups 1 through 3) , Day -1 to Day 11; Part 1: Change from baseline in sodium/potassium (Na/K) ratio (Group 4) , Day 8 to Day 19; Part 2: Change from baseline in sodium/potassium (Na/K) ratio (Groups 1 through 3) , Day -1 to Day 11; Part 2: Change from baseline in sodium/potassium (Na/K) ratio (Group 4) , Day 8 to Day 19; Part 1: Change from baseline in fractional excretion of sodium (FENa; %) (Groups 1 through 3) , Day -1 to Day 11; Part 1: Change from baseline in fractional excretion of sodium (FENa; %) (Group 4) , Day 8 to Day 19; Part 2: Change from baseline in fractional excretion of sodium (FENa; %) (Groups 1 through 3) , Day -1 to Day 11; Part 2: Change from baseline in fractional excretion of sodium (FENa; %) (Group 4) , Day 8 to Day 19. Brief summary: This is a 2-part, 2 periods per part, open-label study with spironolactone oral suspension in pediatric patients with edema due to HF or hepatic cirrhosis. Both study parts will evaluate the safety, PK and PD of multiple doses of spironolactone in patients aged from birth to ≤17 years of age.