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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00913653
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1

Study Details

Study Description

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

• Study Type: Interventional
• 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 1, 2009
• Actual Primary Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stable heart failure patients	Drug: LCZ696

Outcome Measures

Primary Outcome Measures

1. Safety (including blood pressure, renal function and serum electrolytes) and tolerability of LCZ696 [14 days]

Secondary Outcome Measures

1. Pharmacokinetics of LCZ696 and its metabolites [14 days]

2. Pharmacodynamics of LCZ696 [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	GOUVPO Russian Peoples´ Friendship University, Center of Applied	Moscow		Russian Federation	117198

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CLCZ696A2117 from the Novartis Clinical Trials Website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00913653
• Other Study ID Numbers: CLCZ696A2117
• First Posted: Jun 4, 2009
• Last Update Posted: Dec 19, 2020
• Last Verified: Nov 1, 2016

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Heart failure; LCZ696
• Additional relevant MeSH terms: Heart Failure; Sacubitril and valsartan sodium hydrate drug combination

Study Results

No Results Posted as of Dec 19, 2020