Skip to content

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508736-62-00
Acronym
CRD-750-201
Enrollment
265
Registered
2024-05-14
Start date
2024-08-08
Completion date
2025-10-10
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure (HF) with reduced ejection fraction (HFrEF)

Brief summary

The percent change from baseline (pre-dose on Day 1) in plasma NT-proBNP for Doses 2 and 3 at Week 12

Detailed description

The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP at Week 12, The percent change from baseline (pre-dose on Day 1) in BNP at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to NT-proBNP ratio at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to BNP ratio at Week 12, The change from baseline (pre-dose on Day 1) in the KCCQ-23-CSS at Week 12 and the post-baseline NYHA classification at Week 12, The percent change from baseline (pre-dose on Day 1) in plasma NT proBNP at Week 12 for Dose 1

Interventions

Sponsors

Cardurion Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The percent change from baseline (pre-dose on Day 1) in plasma NT-proBNP for Doses 2 and 3 at Week 12

Secondary

MeasureTime frame
The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP at Week 12, The percent change from baseline (pre-dose on Day 1) in BNP at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to NT-proBNP ratio at Week 12, The percent change from baseline (pre-dose on Day 1) in urine and plasma cGMP to BNP ratio at Week 12, The change from baseline (pre-dose on Day 1) in the KCCQ-23-CSS at Week 12 and the post-baseline NYHA classification at Week 12, The percent change from baseline (pre-dose on Day 1) in plasma NT proBNP at Week 12 for Dose 1

Countries

Belgium, Bulgaria, Czechia, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026