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

Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01646671
First received: July 18, 2012
Last updated: October 2, 2015
Last verified: October 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: Severe Hypertension
Intervention: 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
No text entered.

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 200 mg All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
LCZ696 400 mg All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
LCZ696 400 mg Plus Other Hypertension (HTN) Medications All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.

Participant Flow:   Overall Study
    LCZ696 200 mg   LCZ696 400 mg   LCZ696 400 mg Plus Other Hypertension (HTN) Medications
STARTED   3   11   21 
COMPLETED   3   11   21 
NOT COMPLETED   0   0   0 



  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.
Treatment Assignment Set (TRTAG): This set included all patients who entered the treatment epoch.

Reporting Groups
  Description
LCZ696 200 mg All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
LCZ696 400 mg All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
LCZ696 400 mg Plus Other Hypertension (HTN) Medications All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
Total Total of all reporting groups

Baseline Measures
   LCZ696 200 mg   LCZ696 400 mg   LCZ696 400 mg Plus Other Hypertension (HTN) Medications   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   11   21   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.0  (4.0)   56.0  (12.24)   49.3  (7.57)   51.3  (9.45) 
Gender 
[Units: Participants]
       
Female   0   2   0   2 
Male   3   9   21   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths   [ Time Frame: Week 8 ]

2.  Secondary:   Change From Baseline in msSBP and msDBP at Week 8   [ Time Frame: Baseline, 8 weeks ]

3.  Secondary:   Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study   [ Time Frame: 8 weeks ]

4.  Secondary:   Percentage of Participants Achieving Successful msSBP Control at End of Study   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants Achieving Successful msDBP Control at End of Study   [ Time Frame: 8 weeks ]

6.  Secondary:   Percentage of Participants With SBP Response at End of Study   [ Time Frame: Baseline, 8 weeks ]

7.  Secondary:   Percentage of Participants With DBP Response at End of Study   [ Time Frame: Baseline, 8 weeks ]


  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 Pharmaceuticals
phone: +1-862-778-8300


Publications of Results:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01646671     History of Changes
Other Study ID Numbers: CLCZ696A1305
Study First Received: July 18, 2012
Results First Received: July 8, 2015
Last Updated: October 2, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare