Status:
COMPLETED
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) tria...
Eligibility Criteria
Inclusion
- Written informed consent for the extension must be obtained before any assessment is performed.
- Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.
Exclusion
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
- Known history of angioedema
- Requirement of simultaneous treatment with both ACEIs and ARBs
- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- Symptomatic hypotension and/or a SBP \< 100 mmHg at Visit 1 (screening)
- Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
- Presence of bilateral renal artery stenosis
- Serum potassium \> 5.2 mmol/L at Visit 1 (screening)
- Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Key Trial Info
Start Date :
October 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2017
Estimated Enrollment :
1980 Patients enrolled
Trial Details
Trial ID
NCT02226120
Start Date
October 16 2014
End Date
December 28 2017
Last Update
February 20 2019
Active Locations (394)
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1
Novartis Investigative Site
Huntsville, Alabama, United States, 35801
2
Novartis Investigative Site
Muscle Shoals, Alabama, United States, 35662
3
Novartis Investigative Site
Little Rock, Arkansas, United States, 72204
4
Novartis Investigative Site
Oceanside, California, United States, 92056