NCT00913653CompletedPhase 2
An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696
Study Overview
Brief Summary
This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with documented heart failure (NYHA class II-IV)
Exclusion Criteria
- •Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening
Arms & Interventions
Stable heart failure patients
Experimental
Intervention: LCZ696 (Drug)
Outcomes
Primary Outcomes
Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696
Time Frame: 14 days
Secondary Outcomes
- Pharmacokinetics of LCZ696 and its metabolites(14 days)
- Pharmacodynamics of LCZ696(14 days)
Investigators
Study Sites (1)
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