Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01631864
First received: June 27, 2012
Last updated: July 11, 2015
Last verified: June 2015
Results First Received: July 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Conditions: Hypertension
Concurrent Obesity
Interventions: Drug: LCZ696
Drug: amlodipine
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
LCZ696 LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
Amlodipine amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks

Participant Flow:   Overall Study
    LCZ696     Amlodipine  
STARTED     50     48  
COMPLETED     48     44  
NOT COMPLETED     2     4  
Withdrawal by Subject                 0                 1  
Adverse Event                 2                 3  



  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 LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
Amlodipine amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
Total Total of all reporting groups

Baseline Measures
    LCZ696     Amlodipine     Total  
Number of Participants  
[units: participants]
  50     48     98  
Age  
[units: Years]
Mean (Standard Deviation)
  51.9  (9.6)     50.5  (9.4)     51.2  (9.5)  
Gender  
[units: Participants]
     
Female     9     13     22  
Male     41     35     76  



  Outcome Measures
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1.  Primary:   Change From Baseline in Insulin Sensitivity Index   [ Time Frame: baseline, 8 weeks ]

2.  Secondary:   Local Adipose Tissue Lipolysis, Glycerol Concentrations   [ Time Frame: 57 days ]

3.  Secondary:   Oxidative Metabolism   [ Time Frame: 57 days ]

4.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Deaths   [ 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: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01631864     History of Changes
Other Study ID Numbers: CLCZ696B2207, 2012-002606-40
Study First Received: June 27, 2012
Results First Received: July 11, 2015
Last Updated: July 11, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board (MEB)