Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00765947
First received: October 2, 2008
Last updated: March 8, 2011
Last verified: March 2011
Results First Received: December 13, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Essential Hypertension ( Mild to Moderate)
Interventions: Drug: Aliskiren
Drug: Hydrochlorothiazide
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
No text entered.

Reporting Groups
  Description
Aliskiren-based Regimen Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.

Participant Flow:   Overall Study
    Aliskiren-based Regimen  
STARTED     256  
COMPLETED     232  
NOT COMPLETED     24  



  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
Aliskiren-based Regimen Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.

Baseline Measures
    Aliskiren-based Regimen  
Number of Participants  
[units: participants]
  256  
Age, Customized  
[units: participants]
 
< 65 yrs     203  
≥ 65 yrs     53  
Gender  
[units: participants]
 
Female     113  
Male     143  



  Outcome Measures
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1.  Primary:   Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen   [ Time Frame: 24 weeks ]

2.  Secondary:   Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.   [ Time Frame: 24 weeks ]

3.  Secondary:   Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]   [ Time Frame: 24 weeks ]

5.  Secondary:   Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00765947     History of Changes
Other Study ID Numbers: CSPP100A2360
Study First Received: October 2, 2008
Results First Received: December 13, 2010
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Romania: National Medicines Agency