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 30, 2012
Last verified: November 2012

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:

Primary Outcome Measures:
  • Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of LCZ696 and its metabolites [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics of LCZ696 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00913653     History of Changes
Other Study ID Numbers: CLCZ696A2117
Study First Received: June 2, 2009
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 17, 2014