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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01785472
First received: February 5, 2013
Last updated: August 6, 2015
Last verified: August 2015
Results First Received: August 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: LCZ696
Drug: Olmesartan
Drug: Placebo of LCZ696
Drug: Placebo of Olmesartan

  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
No text entered.

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 200 mg Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
LCZ696 400 mg Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
Olmesartan 20 mg Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.

Participant Flow:   Overall Study
    LCZ696 200 mg     LCZ696 400 mg     Olmesartan 20 mg  
STARTED     479     473     486  
Full Analysis Set (FAS)     479     472     484  
Safety Set (SAF)     478     472     484  
COMPLETED     455     454     464  
NOT COMPLETED     24     19     22  
Adverse Event                 5                 4                 6  
Lack of Efficacy                 2                 0                 1  
Lost to Follow-up                 1                 2                 0  
Physician Decision                 1                 1                 1  
Protocol deviation                 0                 2                 2  
Subject/guardian decision                 15                 10                 11  
Technical problems                 0                 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.
Full Analysis Set (FAS): All patients who were randomized. Patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS, provided these patients did not receive study drug

Reporting Groups
  Description
LCZ696 200 mg Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
LCZ696 400 mg Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
Olmesartan 20 mg Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
Total Total of all reporting groups

Baseline Measures
    LCZ696 200 mg     LCZ696 400 mg     Olmesartan 20 mg     Total  
Number of Participants  
[units: participants]
  479     472     484     1435  
Age  
[units: Years]
Mean (Standard Deviation)
  57.5  (10.17)     58.1  (9.71)     57.4  (10.14)     57.7  (10.01)  
Gender  
[units: Participants]
       
Female     227     229     223     679  
Male     252     243     261     756  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg   [ Time Frame: baseline, 8 weeks ]

2.  Secondary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg   [ Time Frame: baseline, 8 weeks ]

3.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg   [ Time Frame: baseline, 8 weeks ]

4.  Secondary:   Change From Baseline in Office Pulse Pressure (msPP)   [ Time Frame: baseline, 8 weeks ]

5.  Secondary:   Change From Baseline in Mean 24-hour Ambulatory Blood Pressure   [ Time Frame: baseline, 8 weeks ]

6.  Secondary:   Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.   [ Time Frame: baseline, 8 weeks ]

7.  Secondary:   Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.   [ Time Frame: baseline, 8 weeks ]

8.  Secondary:   Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.   [ Time Frame: baseline, 8 weeks ]

9.  Secondary:   Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.   [ Time Frame: baseline, 8 weeks ]

10.  Secondary:   Percentage of Patients Achieving Successful Blood Pressure Control   [ Time Frame: 8 weeks ]

11.  Secondary:   Change From Baseline in Ambulatory Pulse Pressure   [ Time Frame: baseline, 8 weeks ]

12.  Secondary:   Number of Responders   [ Time Frame: baseline, 8 weeks ]

13.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability   [ Time Frame: baseline, 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
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01785472     History of Changes
Other Study ID Numbers: CLCZ696A2315
CLCZ696A2315 ( Other Identifier: Novartis )
Study First Received: February 5, 2013
Results First Received: August 6, 2015
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration