Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/22/2019
Start Date:October 16, 2014
End Date:December 28, 2017

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A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

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) trial was terminated early due to compelling efficacy of LCZ696 in patients
with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified
interim analysis in March 2014.


Inclusion Criteria:

1. Written informed consent for the extension must be obtained before any assessment is
performed.

2. 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 Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of enrollment, whichever is longer

2. 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

3. Known history of angioedema

4. Requirement of simultaneous treatment with both ACEIs and ARBs

5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
symptoms that may require intravenous therapy)

6. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 (screening)

7. Estimated GFR < 30 mL/min/1.73m^2 as measured by the simplified MDRD formula at Visit
1 (screening)

8. Presence of bilateral renal artery stenosis

9. Serum potassium > 5.2 mmol/L at Visit 1 (screening)

10. 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

11. Pregnant or nursing (lactating) women

12. Women of child-bearing potential

13. 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.
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Boynton Beach, Florida 33437
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Caba, Buenos Aires
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Des Moines, Iowa 50314
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Fremont, Nebraska 68025
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Huntsville, Alabama 35801
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Little Rock, Arkansas 72204
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Livingston, Texas 77351
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Marion, Ohio 43302
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Minneapolis, Minnesota 55402
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Muscle Shoals, Alabama 35662
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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