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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

PHRR150622-001012

CLCZ696B2317

2015-CT0280

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

In order to provide patients the opportunity to receive life-saving treatment with LCZ696 and to collect safety data, this open-label, safety and tolerability study will offer enrollment to all surviving, eligible patients that had been randomized in PARADIGM-HF.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-06-30 30 2017-12-30 2016-09-30

Completed

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR
Institution Region
Novartis Healthcare Philippines, Inc. NCR
Name E-Mail Institution and Institution Address
Carina Barlongo carina.barlongo@novartis.com 2nd Flr Asian Reinsurance Building Salcedo cor Gamboa Sts. Legaspi Village Makati City
Name E-Mail Institution and Institution Address
Carina Barlongo carina.barlongo@novartis.com 2nd Flr Asian Reinsurance Building Salcedo cor Gamboa Sts. Legaspi Village Makati City
Name Expertise Affiliation
Adriel Guerrero, MD Cardiologist The Medical City
Annette Borromeo, MD Cardiologist Philippine Heart Center
Antonio S. Sibulo, Jr., MD Cardiologist St. Luke's Medical Center - Quezon City
Arthur M. Ferrolino, MD Cardiologist Veterans Memorial Medical Center
Gregorio G. Rogelio, MD Cardiologist St. Luke's Medical Center - Quezon City
John C. Anonuevo, MD Cardiologist Manila Doctors Hospital
Romulo Rosita, MD Cardiologist Mary Mediatrix Medical Center
Sue Ann R. Locnen, MD Cardiologist St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
The Medical City The Medical City - Institutional Review Board
Philippine Heart Center Philippine Heart Center Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Veterans Memorial Medical Center Veterans Memorial Medical Center Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Mary Mediatrix Medical Center Mary Mediatrix Medical Center Research Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

chronic heart failure

The primary objective of this study is to continue to evaluate the safety and tolerability of LCZ696 in heart failure patients from PARADIGM-HF receiving open-label investigational drug.

not applicable

Completed

  • Philippines

Clinical Trial

CLCZ696B2317

Unspecified

2015-05-08

0000-00-00

60

60

Unspecified

2015-08-12

  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.

Interventional

LCZ696

  • LCZ696 50 mg film-coated tablets (LCZ696 dose level 1)
  • LCZ696 100 mg film-coated tablets (LCZ696 dose level 2)
  • LCZ696 200 mg film-coated tablets (LCZ696 dose level 3)

None

Unspecified

Open Label

Unspecified

Unspecified

The purpose of this study is to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients receiving open-label investigational drug. The study has a minimum duration of 15 months and is expected to continue until marketing authorizations
have been received in the participating countries and the drug product becomes commercially available, which is anticipated to be up to approximately 30 months.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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