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

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226120
• Other study ID #: CLCZ696B2317
• Secondary ID: 2014-001971-30
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2014
• Est. completion date: December 28, 2017

Study information

• Verified date: February 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1980
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

Drug:
• LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Capital Federal
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad de Salta	Provincia De Salta
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Formosa
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Luis
Argentina	Novartis Investigative Site	San Salvador de Jujuy	Jujuy
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santiago del Estero
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	La Louviere
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Ronse
Brazil	Novartis Investigative Site	Belem	PA
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Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Goiania	GO
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Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
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Russian Federation	Novartis Investigative Site	Saint Petersburg
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Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
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Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
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Slovakia	Novartis Investigative Site	Bratislava
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Slovakia	Novartis Investigative Site	Kosice
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Slovakia	Novartis Investigative Site	Martin
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South Africa	Novartis Investigative Site	Alberton
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United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Livingston	Texas
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United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Muscle Shoals	Alabama
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Palm Springs	California
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Rosedale	New York
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	San Diego	California
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United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Guatemala,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696	The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.	From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.