Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01922089
First received: August 12, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.


Condition Intervention Phase
Heart Failure With Reduced Ejection Fraction
Drug: LCZ696
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients experiencing specified adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with systolic blood pressure < 95 mmHg [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with abnormal serum creatinine and doubling of serum creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with Serum potassium > 5.5 mmol/l and ≥ 6.0 mmol/l [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients who achieve treatment success [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients who tolerate study medication for at least the last two weeks of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 499
Study Start Date: November 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Condensed up-titration
Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
Drug: LCZ696
LCZ696 50 mg/100 mg/200 mg bid
Experimental: Conservative up-titration
Up-titration to LCZ696 200 mg bid over 6 weeks
Drug: LCZ696
LCZ696 50 mg/100 mg/200 mg bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

  • Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922089

  Hide Study Locations
Locations
United States, Alaska
Novartis Investigative Site
Anchorage, Alaska, United States, 99508
United States, Arizona
Novartis Investigative Site
Gilbert, Arizona, United States, 85297
Novartis Investigative Site
Tucson, Arizona, United States, 85710
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
Novartis Investigative Site
Torrance, California, United States, 90502
United States, Florida
Novartis Investigative Site
Atlantis, Florida, United States, 33462
Novartis Investigative Site
Chiefland, Florida, United States, 32626
United States, Illinois
Novartis Investigative Site
Aurora, Illinois, United States, 60504
Novartis Investigative Site
Peoria, Illinois, United States, 61602
United States, Indiana
Novartis Investigative Site
Evansville, Indiana, United States, 47714
United States, Louisiana
Novartis Investigative Site
Slidell, Louisiana, United States, 70458
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63110
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14215
Novartis Investigative Site
Laurelton, New York, United States, 11422
United States, Ohio
Novartis Investigative Site
Marion, Ohio, United States, 43302
United States, Tennessee
Novartis Investigative Site
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75231
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
Houston, Texas, United States, 77094
Novartis Investigative Site
Livingston, Texas, United States, 77351
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98405
Bulgaria
Novartis Investigative Site
Gabrovo, Bulgaria, 5300
Novartis Investigative Site
Plovdiv, Bulgaria, 4000
Novartis Investigative Site
Plovdiv, Bulgaria, 4004
Novartis Investigative Site
Smolian, Bulgaria, 4700
Novartis Investigative Site
Sofia, Bulgaria, 1202
Novartis Investigative Site
Sofia, Bulgaria, 1407
Finland
Novartis Investigative Site
Jyvaskyla, Finland, 40620
Novartis Investigative Site
Tampere, Finland, 33520
Germany
Novartis Investigative Site
Anderbeck, Germany, 38836
Novartis Investigative Site
Bad Krozingen, Germany, 79189
Novartis Investigative Site
Berlin, Germany, 10367
Novartis Investigative Site
Berlin, Germany, 13405
Novartis Investigative Site
Berlin, Germany, 10789
Novartis Investigative Site
Berlin, Germany, 13055
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Berlin, Germany, 13347
Novartis Investigative Site
Berlin, Germany, 10787
Novartis Investigative Site
Berlin-Buch, Germany, 13125
Novartis Investigative Site
Dietzenbach, Germany, 63128
Novartis Investigative Site
Ebersbach, Germany, 02730
Novartis Investigative Site
Frankfurt, Germany, 60594
Novartis Investigative Site
Göttingen, Germany, D-37075
Novartis Investigative Site
Hassloch, Germany, 67454
Novartis Investigative Site
Ingelheim, Germany, 55218
Novartis Investigative Site
Kelkheim, Germany, 65779
Novartis Investigative Site
Kleve, Germany, 47533
Novartis Investigative Site
Leipzig, Germany, 04315
Novartis Investigative Site
Mainz, Germany, 55116
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Mühlheim, Germany, 45468
Novartis Investigative Site
Siegen, Germany, 57072
Novartis Investigative Site
Straubing, Germany, 94315
Novartis Investigative Site
Würzburg, Germany, 97078
Hungary
Novartis Investigative Site
Budapest, Hungary, H-1096
Novartis Investigative Site
Budapest, Hungary, 1145
Novartis Investigative Site
Budapest, Hungary, 1042
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Mosonmagyarovar, Hungary, 9200
Novartis Investigative Site
Nyiregyháza, Hungary, 4400
Novartis Investigative Site
Pecs, Hungary, 7623
Novartis Investigative Site
Szekesfehervar, Hungary, 8000
Italy
Novartis Investigative Site
Aosta, AO, Italy, 11100
Novartis Investigative Site
Cortona, AR, Italy, 52044
Novartis Investigative Site
Bergamo, BG, Italy, 24128
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Albano Laziale, RM, Italy, 00041
Novartis Investigative Site
Roma, RM, Italy, 00163
Novartis Investigative Site
Sassari, SS, Italy, 07100
Novartis Investigative Site
Vittorio Veneto, TV, Italy, 31029
Novartis Investigative Site
San Daniele Del Friuli, UD, Italy, 33038
Puerto Rico
Novartis Investigative Site
San Juan, Puerto Rico, 00936-6528
Slovakia
Novartis Investigative Site
Brezno, Slovak Republic, Slovakia, 977 42
Novartis Investigative Site
Nitra, Slovak republic, Slovakia, 95201
Novartis Investigative Site
Svidnik, Slovak Republic, Slovakia, 08901
Novartis Investigative Site
Bratislava, Slovakia, 821 07
Novartis Investigative Site
Bratislava, Slovakia, 83301
Novartis Investigative Site
Kosice, Slovakia, 040 01
Novartis Investigative Site
Lucenec, Slovakia, 98439
Novartis Investigative Site
Nove Zamky, Slovakia, 940 01
Novartis Investigative Site
Trebisov, Slovakia, 075 01
Spain
Novartis Investigative Site
Almeria, Andalucia, Spain, 04120
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Sanlúcar de Barrameda, Andalucia, Spain, 11540
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site
Villamartin, Andalucia, Spain, 11650
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
A Coruña, Galicia, Spain, 15006
Novartis Investigative Site
Madrid, Spain, 28009
Turkey
Novartis Investigative Site
Haydarpasa/Istanbul, Turkey, 34668
Novartis Investigative Site
Istanbul, Turkey, 34304
Novartis Investigative Site
Kocaeli, Turkey, 41380
Novartis Investigative Site
Mersin, Turkey, 33079
Novartis Investigative Site
Sivas, Turkey, 58140
United Kingdom
Novartis Investigative Site
Dorchester, Dorset, United Kingdom, DT1 2JY
Novartis Investigative Site
St Leonards on Sea, East Sussex, United Kingdom, TN37 7RD
Novartis Investigative Site
Oldham, Lancashire, United Kingdom, OL1 2JH
Novartis Investigative Site
Gateshead, Tyne and Wear, United Kingdom, NE9 6SX
Novartis Investigative Site
Bath, United Kingdom, BA1 3NG
Novartis Investigative Site
Bradford, United Kingdom, BD9 6RJ
Novartis Investigative Site
Coventry, United Kingdom, CV2 2DX
Novartis Investigative Site
Harrow, United Kingdom, HA1 3UJ
Novartis Investigative Site
Nuneaton, United Kingdom, CV10 7DJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01922089     History of Changes
Other Study ID Numbers: CLCZ696B2228, 2013-001835-33
Study First Received: August 12, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Slovak Republic: Ethics Committee
Italy: Ministry of Health
Spain: Ministry of Health
Turkey: Ministry of Health
Bulgaria: Ministry of Health
Hungary: Institutional Ethics Committee
Finland: Ministry of Social Affairs and Health
Norway: Norwegian Medicines Agency

Keywords provided by Novartis:
Heart failure, reduced ejection fraction, LCZ696, titration, safety, tolerability

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014