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Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 2, 2009
Last updated: November 16, 2016
Last verified: November 2016
This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Condition Intervention Phase
Heart Failure Drug: LCZ696 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696 [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Pharmacokinetics of LCZ696 and its metabolites [ Time Frame: 14 days ]
  • Pharmacodynamics of LCZ696 [ Time Frame: 14 days ]

Enrollment: 30
Study Start Date: May 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stable heart failure patients Drug: LCZ696


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with documented heart failure (NYHA class II-IV)

Exclusion Criteria:

  • Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening
  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 identifier: NCT00913653

Russian Federation
GOUVPO Russian Peoples´ Friendship University, Center of Applied
Moscow, Russian Federation, 117198
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00913653     History of Changes
Other Study ID Numbers: CLCZ696A2117
Study First Received: June 2, 2009
Last Updated: November 16, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017