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

March 16, 2011
April 2, 2014
March 2011
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01353508 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers
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

Assess mechanism of action of LCZ696 related to sodium excretion.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
Drug: LCZ696
  • Experimental: Patients with stable heart failure
    Intervention: Drug: LCZ696
  • Experimental: Patients with hypertension
    Intervention: Drug: LCZ696
  • Experimental: Healthy volunteers
    Intervention: Drug: LCZ696
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01353508
CLCZ696B2223
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP