Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01681576
First received: August 30, 2012
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Salt-sensitive Hypertension
Interventions: Drug: Valsartan
Drug: LCZ696

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Period 1: 4 weeks treatment with LCZ696 400mg QD or Valsartan 320mg, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with Valsartan 320mg QD or LCZ696 400mg QD

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LCZ696 Followed by Valsartan Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
Valsartan Followed by LCZ696 Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks

Participant Flow for 2 periods

Period 1:   Period 1
    LCZ696 Followed by Valsartan   Valsartan Followed by LCZ696
STARTED   36   36 
COMPLETED   34   36 
NOT COMPLETED   2   0 
Adverse Event                1                0 
Protocol Deviation                1                0 

Period 2:   Period 2
    LCZ696 Followed by Valsartan   Valsartan Followed by LCZ696
STARTED   34 [1]   36 [2] 
COMPLETED   30   35 
NOT COMPLETED   4   1 
subject/guardian decision                3                1 
Non-compliance with study treatment                1                0 
[1] Period 2: Valsartan 320mg
[2] Period 2: LCZ696 400mg



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LCZ696 Followed by Valsartan Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
Valsartan 320mg Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
Total Total of all reporting groups

Baseline Measures
   LCZ696 Followed by Valsartan   Valsartan 320mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (12.5)   58.9  (7.5)   57.3  (10.3) 
Gender 
[Units: Participants]
     
Female   13   13   26 
Male   23   23   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Sodium Excretion (Natriuresis) at Day 1   [ Time Frame: 0-6 and 0-24 hours on Day 1 ]

2.  Secondary:   Cumulative Sodium Excretion (Natriuresis) at Day 28   [ Time Frame: 0-6 and 0-24 hours on Day 28 ]

3.  Secondary:   Urine Volume (Diuresis) Over Time   [ Time Frame: Day -1, Day 1 & Day 28 ]

4.  Secondary:   Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time   [ Time Frame: Day-1, Day 14 and Day 28 ]

5.  Secondary:   Mean Sitting Pulse Pressure (PP) Over Time   [ Time Frame: Day-1, Day 14 and Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01681576     History of Changes
Other Study ID Numbers: CLCZ696A2222
Study First Received: August 30, 2012
Results First Received: July 10, 2015
Last Updated: October 12, 2015
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan: Department of Health
Singapore: Health Sciences Authority
Hong Kong: Ethics Committee