Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01615198
First received: June 6, 2012
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: July 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: Olmesartan
Drug: Placebo
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 Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
Olmesartan Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

Participant Flow:   Overall Study
    LCZ696     Olmesartan  
STARTED     296     292  
Full Analysis Set     296     292  
Ambulatory BP Monitoring (ABPM) Subset     154     157  
Safety Set     296     292  
ABPM Dipper Status Subset     82     84  
COMPLETED     272     273  
NOT COMPLETED     24     19  
Withdrawal by Subject                 5                 5  
Protocol deviation                 1                 1  
Physician Decision                 5                 1  
Lost to Follow-up                 1                 1  
Lack of Efficacy                 1                 6  
Adverse Event                 11                 5  



  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 Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
Olmesartan Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
Total Total of all reporting groups

Baseline Measures
    LCZ696     Olmesartan     Total  
Number of Participants  
[units: participants]
  296     292     588  
Age  
[units: Years]
Mean (Standard Deviation)
  70.5  (4.67)     70.9  (4.67)     70.7  (4.67)  
Gender  
[units: Participants]
     
Female     154     140     294  
Male     142     152     294  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: Baseline, 10 weeks ]

2.  Secondary:   Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)   [ Time Frame: Baseline, 10 weeks ]

3.  Secondary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: Baseline, 4 weeks, 14 weeks ]

4.  Secondary:   Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)   [ Time Frame: Baseline, 10 weeks ]

5.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: Baseline, 10 weeks ]

6.  Secondary:   Change From Baseline in Mean Sitting Pulse Pressure   [ Time Frame: Baseline, 4 weeks, 10 weeks, 14 weeks ]

7.  Secondary:   Change From Baseline in Daytime and Nighttime maSBP/maDBP   [ Time Frame: Baseline, 10 weeks ]

8.  Secondary:   Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers   [ Time Frame: Baseline, 10 weeks ]

9.  Secondary:   Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers   [ Time Frame: Baseline, 10 weeks ]

10.  Secondary:   Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: 4 weeks, 10 weeks, 14 weeks ]

11.  Secondary:   Number of Participants Achieving Successful Response in msSBP and msDBP   [ Time Frame: 4 weeks,10 weeks, 14 weeks ]

12.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Death   [ Time Frame: 14 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
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01615198     History of Changes
Other Study ID Numbers: CLCZ696A2316
Study First Received: June 6, 2012
Results First Received: July 20, 2015
Last Updated: July 20, 2015
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labor and Welfare
Taiwan: Department of Health
Thailand: Ministry of Public Health
Hong Kong: Department of Health
Philippines: Department of Health