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Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01353508
First received: March 16, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

Assess mechanism of action of LCZ696 related to sodium excretion.


Condition Intervention Phase
Hypertension
 Drug: LCZ696
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled, Crossover Study to Evaluate the Sodium Excretion of LCZ696 in Patients With Stable Heart Failure, in Patients With Hypertension, and in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Comparison of the 24-hour and the cumulative 7-day sodium and urine excretion volume of subjects on LCZ696 compared to subjects on Valsartan or placebo. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the cumulative 7-day sodium excretion and urine output with the AUC (Area under the plasma concentration versus time curve) and Cmax (Peak Plasma concentration) of LCZ696 with Valsartan or placebo. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • To compare the changes in the biomarkers ANP, BNP and cGMP with the AUC and Cmax of subjects on LCZ696 with Valsartan or placebo. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • To assess number of patients with adverse events, abnormal lab values, discontinuation of subjects on LCZ696 versus Valsartan or placebo. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with stable heart failure Drug: LCZ696 Drug: LCZ696 Drug: LCZ696
Experimental: Patients with hypertension Drug: LCZ696 Drug: LCZ696 Drug: LCZ696
Experimental: Healthy volunteers Drug: LCZ696 Drug: LCZ696 Drug: LCZ696

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects: not on regular medication for any medical condition
  • Patients with heart failure: documented NYHA class II-III heart failure
  • Patients with hypertension: stable hypertensive medication for the preceding 2 months

Exclusion Criteria:

  • Women of childbearing potential
  • History of recent myocardial infarction
  • History of dialysis or renal transplant
  • Patients with type 1 diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353508

Locations
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117198
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01353508     History of Changes
Other Study ID Numbers: CLCZ696B2223
Study First Received: March 16, 2011
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
Sodium excretion,
LCZ696

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013