Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01663233
First received: August 8, 2012
Last updated: July 21, 2015
Last verified: July 2015
Results First Received: July 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: LCZ696
Drug: Amlodipine

  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 and Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.

Participant Flow:   Overall Study
    LCZ696 and Amlodipine     Amlodipine  
STARTED     130     136  
COMPLETED     126     129  
NOT COMPLETED     4     7  
Withdrawal by Subject                 3                 2  
Protocol Deviation                 1                 4  
Lost to Follow-up                 0                 1  



  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 and Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
Amlodipine Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    LCZ696 and Amlodipine     Amlodipine     Total  
Number of Participants  
[units: participants]
  130     136     266  
Age  
[units: Years]
Mean (Standard Deviation)
  55.4  (9.31)     55.5  (9.43)     55.4  (9.35)  
Gender  
[units: Participants]
     
Female     49     61     110  
Male     81     75     156  



  Outcome Measures
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1.  Primary:   Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)   [ Time Frame: 8 weeks ]

3.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: 8 weeks ]

4.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: 8 weeks ]

5.  Secondary:   Change in Sitting Pulse Pressure (PP)   [ Time Frame: 8 weeks ]

6.  Secondary:   Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)   [ Time Frame: 8 weeks ]

7.  Secondary:   Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)   [ Time Frame: 8 weeks ]

8.  Secondary:   Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)   [ Time Frame: 8 weeks of treatment ]

9.  Secondary:   Number of Participants With Adverse Event   [ 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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01663233     History of Changes
Other Study ID Numbers: CLCZ696A2319
Study First Received: August 8, 2012
Results First Received: July 21, 2015
Last Updated: July 21, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
China: Food and Drug Administration
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Taiwan: Center for Drug Evaluation