Status:
TERMINATED
A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This was a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
Detailed Description
Eligible participants were randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks. The study planned to randomize a...
Eligibility Criteria
Inclusion
- Current symptom(s) of HF NYHA class II-III and LVEF \< 50%
- Elevated NT-proBNP levels at screening.
- Receiving standard of care background HF therapy.
Exclusion
- Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
- Current symptomatic hypotension (for example dizziness/presyncope).
- K+ \> 5.4 mmol/L at screening
- eGFR \< 30 mL/min/1.73m2 at screening
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06142383
Start Date
December 12 2023
End Date
November 1 2024
Last Update
December 24 2025
Active Locations (62)
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1
SEC Clinical Research
Dothan, Alabama, United States, 36305
2
Heart Center Research Llc
Huntsville, Alabama, United States, 35801
3
Nature Coast Clinical Research LLC
Inverness, Florida, United States, 34452
4
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States, 33014