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

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: NCT00913653
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: LCZ696 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stable heart failure patients Drug: LCZ696


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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

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
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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): NCT00913653


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

Publications of Results:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00913653    
Other Study ID Numbers: CLCZ696A2117
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: November 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart failure
LCZ696
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
 LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action