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Trial record 1 of 6 for:    paradigm-hf
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Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02226120
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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) 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure With Reduced Ejection Fraction Drug: LCZ696 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1980 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 16, 2014
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
Drug: LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid




Primary Outcome Measures :
  1. Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696 [ Time Frame: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226120


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] March 2, 2018
Study Protocol  [PDF] April 28, 2015

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02226120    
Other Study ID Numbers: CLCZ696B2317
2014-001971-30 ( EudraCT Number )
First Posted: August 27, 2014    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LCZ696
chronic heart failure
ARNI
Congestive heart failure (CHF)
heart failure (HF)
acute heart failure syndrome
congestive cardiac failure (CCF)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action