Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
NCT ID: NCT02226120
Last Updated: 2019-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1980 participants
INTERVENTIONAL
2014-10-16
2017-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Interventions
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LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Huntsville, Alabama, United States
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Muscle Shoals, Alabama, United States
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Little Rock, Arkansas, United States
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2014-001971-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696B2317
Identifier Type: -
Identifier Source: org_study_id
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