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A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01870739
First received: June 3, 2013
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: sacubitril/valsartan (LCZ696)
Drug: olmesartan
Other: placebo to sacubitril/valsartan (LCZ696)
Other: placebo to olmesartan
Drug: Amlodipine (Optional)

  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

A total of 115 patients were enrolled. One patient was discontinued after randomization before receiving any dose of study randomized medication.

A total of 114 patients received study randomized medication


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
Sacubitril/Valsartan (LCZ696) LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
Olmesartan Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)

Participant Flow for 2 periods

Period 1:   Single Drug Treatment (12 Weeks)
    Sacubitril/Valsartan (LCZ696)   Olmesartan
STARTED   57 [1]   57 
Initiation Dose Completed   57   56 
Maintenance Dose Started   57   56 
COMPLETED   54 [2]   53 
NOT COMPLETED   3   4 
Protocol deviation                0                1 
Adverse Event                0                1 
Administrative problems                3                2 
[1] "Start" = Safety/Pharmacokinetic/Pharmacodynamic analysis set
[2] "Completed" indicates maintenance dose complete

Period 2:   Add-on Period (40 Weeks)
    Sacubitril/Valsartan (LCZ696)   Olmesartan
STARTED   54   53 
COMPLETED   51   51 
NOT COMPLETED   3   2 
Adverse Event                0                1 
Unsatisfactory therapeutic effect                1                0 
Protocol deviation                1                1 
Patient withdrew consent                1                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.
Safety analysis set: All patients that received study drug

Reporting Groups
  Description
Sacubitril/Valsartan (LCZ696) LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
Olmesartan Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
Total Total of all reporting groups

Baseline Measures
   Sacubitril/Valsartan (LCZ696)   Olmesartan   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   57   114 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.5  (7.8)   59.2  (13.1)   59.8  (10.7) 
Gender 
[Units: Participants]
     
Female   20   17   37 
Male   37   40   77 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Ascending Aorta Distensibility at 52 Week   [ Time Frame: Baseline, 52 weeks ]

2.  Primary:   Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

3.  Primary:   Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

4.  Secondary:   Change From Baseline in Local Aortic Strain at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

5.  Secondary:   Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

6.  Secondary:   Change From Baseline in Central Blood Pressure at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

7.  Secondary:   Change From Baseline in Augmentation Pressure at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

8.  Secondary:   Change From Baseline in Augmentation Index at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

9.  Secondary:   Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks   [ Time Frame: Baseline, 52 weeks ]

10.  Secondary:   Number of Patients With Reported Adverse Events, Serious Adverse Events and Death   [ Time Frame: 12 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: 862-778-8300
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01870739     History of Changes
Other Study ID Numbers: CLCZ696A2224
2012-005720-15 ( EudraCT Number )
Study First Received: June 3, 2013
Results First Received: May 31, 2016
Last Updated: July 20, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices