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A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504678-39-00
Acronym
CXXB750A12201
Enrollment
424
Registered
2024-03-04
Start date
2024-03-13
Completion date
2024-11-08
Last updated
2024-11-08

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

Conditions

Heart Failure

Brief summary

Change in log NT-proBNP from baseline to Week 16

Detailed description

Change in log NT-proBNP from baseline to Week 16, Adverse events, safety laboratory parameters, and vital signs from baseline to end of study (EOS)

Interventions

DRUGLISINOPRIL
DRUGXXB750
DRUGCANDESARTAN
DRUGPERINDOPRIL
DRUGCAPTOPRIL
DRUGRAMIPRIL
DRUGIRBESARTAN
DRUGDELAPRIL
DRUGOLMESARTAN MEDOXOMIL
DRUG0 mg/1 mL Placebo to XXB750 150 mg/1 mL concentrate for solution for injection
DRUGENALAPRIL
DRUGTELMISARTAN
DRUGVALSARTAN
DRUGLOSARTAN

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in log NT-proBNP from baseline to Week 16

Secondary

MeasureTime frame
Change in log NT-proBNP from baseline to Week 16, Adverse events, safety laboratory parameters, and vital signs from baseline to end of study (EOS)

Countries

Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain

Outcome results

None listed

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