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: April 2, 2014
Last verified: April 2014
  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:


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: 32
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
Experimental: Patients with hypertension Drug: LCZ696
Experimental: Healthy volunteers 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 2, 2014
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 July 28, 2014