Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
Completed · Phase 2
Conditions studied: Heart Failure With Reduced Ejection Fraction
In brief
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
Key facts
- Study ID
- NCT01922089
- Run by
- Novartis Pharmaceuticals
- People needed
- 498
- Starts
- 2013-11-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2015-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers
You may not qualify if…
- Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Novartis Investigative Site — Gilbert, Arizona, United States
- Novartis Investigative Site — Tucson, Arizona, United States
- Novartis Investigative Site — Anaheim, California, United States
- Novartis Investigative Site — Torrance, California, United States
- Novartis Investigative Site — Atlantis, Florida, United States
- Novartis Investigative Site — Chiefland, Florida, United States
- Novartis Investigative Site — Aurora, Illinois, United States
- Novartis Investigative Site — Peoria, Illinois, United States
- Novartis Investigative Site — Evansville, Indiana, United States
- Novartis Investigative Site — Slidell, Louisiana, United States
- Novartis Investigative Site — Minneapolis, Minnesota, United States
- Novartis Investigative Site — St Louis, Missouri, United States
- Novartis Investigative Site — Buffalo, New York, United States
- Novartis Investigative Site — Laurelton, New York, United States
- Novartis Investigative Site — Marion, Ohio, United States
- Novartis Investigative Site — Oak Ridge, Tennessee, United States
- Novartis Investigative Site — Dallas, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Livingston, Texas, United States
- Novartis Investigative Site — Tacoma, Washington, United States
- Novartis Investigative Site — Gabrovo, Bulgaria, Bulgaria
- Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
- Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
- Novartis Investigative Site — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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