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NCT00913653 Clinical Trial

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

Heart Failure Clinical Trial

Official title:
An Open Label, Non-randomised Study to Explore Safety/Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 in Patients With Stable Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00913653
Other study ID # CLCZ696A2117
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2009

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LCZ696

Locations
Country Name City State
Russian Federation GOUVPO Russian Peoples´ Friendship University, Center of Applied Moscow

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Kobalava Z, Kotovskaya Y, Averkov O, Pavlikova E, Moiseev V, Albrecht D, Chandra P, Ayalasomayajula S, Prescott MF, Pal P, Langenickel TH, Jordaan P, Rajman I. Pharmacodynamic and Pharmacokinetic Profiles of Sacubitril/Valsartan (LCZ696) in Patients with — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696 14 days
Secondary Pharmacokinetics of LCZ696 and its metabolites 14 days
Secondary Pharmacodynamics of LCZ696 14 days
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