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Ruboxistaurin in NYHA Class III-IV Heart Failure
NCT02769611Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jun 2017
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- University of Tennessee
- Modality
- Small Molecules
- Drugs
- ruboxistaurin
- Conditions
- heart failure (HF)
01
Overview
Phase 2, open-label trial of ruboxistaurin in heart failure (HF) (3 arms), sponsored by University of Tennessee. Primary endpoints: Percent of patients with a new onset, clinically significant arrhythmia or conduction system disease at 48 hours, Percent of patients with significant prolongation in the corrected QT (QTc) interval at 24 hours and 3 more. Planned start Jun 2017; status: withdrawn.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Ruboxistaurin 64 mg
Single dose of 64 mg
Ruboxistaurin 128 mg
Single dose of 128 mg
Ruboxistaurin 256 mg
Single dose of 256 mg
03
Endpoints
Primary
Percent of patients with a new onset, clinically significant arrhythmia or conduction system disease
Percent of patients with significant prolongation in the corrected QT (QTc) interval
Percent of patients with significant increase in liver function tests
Percent of patients with a significant increase in serum creatinine not explained by diuretic use
Percent of patient with a significant increase in serum creatine phosphokinase (CPK) levels
Secondary
Percent of patients experiencing at least one adverse event
Change in cardiac contractility as assessed by echocardiography
Change in self-reported well-being, fatigue and dyspnea
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