Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01593787
First received: April 30, 2012
Last updated: August 7, 2015
Last verified: August 2015
Results First Received: July 8, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension With Renal Dysfunction
Intervention: Drug: LCZ696

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LCZ696 100 mg All participants were started on LCZ696 100 mg once daily on day 1.
LCZ696 200 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
LCZ696 400 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.

Participant Flow:   Overall Study
    LCZ696 100 mg     LCZ696 200 mg     LCZ696 400 mg  
STARTED     6     8     18  
COMPLETED     5     8     18  
NOT COMPLETED     1     0     0  
Adverse Event                 1                 0                 0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
LCZ696 100 mg All participants were started on LCZ696 100 mg once daily on day 1.
LCZ696 200 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
LCZ696 400 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
Total Total of all reporting groups

Baseline Measures
    LCZ696 100 mg     LCZ696 200 mg     LCZ696 400 mg     Total  
Number of Participants  
[units: participants]
  6     8     18     32  
Age  
[units: Years]
Mean (Standard Deviation)
  69.0  (5.10)     71.3  (8.80)     62.3  (9.04)     65.8  (9.12)  
Gender  
[units: Participants]
       
Female     2     4     2     8  
Male     4     4     16     24  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)   [ Time Frame: 8 weeks ]

2.  Secondary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8   [ Time Frame: baseline, 8 weeks ]

3.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8   [ Time Frame: baseline, 8 weeks ]

4.  Secondary:   Percentage of Participants Achieving a Successful BP Control at Week 8   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants Achieving SBP Control at Week 8   [ Time Frame: 8 weeks ]

6.  Secondary:   Percentage of Participants Achieving DBP Control at Week 8   [ Time Frame: 8 weeks ]

7.  Secondary:   Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8   [ Time Frame: 8 weeks ]

8.  Secondary:   Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 Pharmaceuticals
phone: +1 (862) 778-8300


Publications:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01593787     History of Changes
Other Study ID Numbers: CLCZ696A1304
Study First Received: April 30, 2012
Results First Received: July 8, 2015
Last Updated: August 7, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare