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A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00368277
First received: August 22, 2006
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
Results First Received: December 14, 2010  
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: Hypertension
Interventions: Drug: Aliskiren
Drug: Ramipril
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
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Reporting Groups
  Description
Aliskiren Based Treatment Regimen Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
Ramipril Based Treatment Regimen Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg

Participant Flow:   Overall Study
    Aliskiren Based Treatment Regimen     Ramipril Based Treatment Regimen  
STARTED     457     444  
COMPLETED     344     336  
NOT COMPLETED     113     108  
Adverse Event                 33                 49  
Death                 2                 1  
Unsatisfactory therapeutic effect                 31                 24  
Protocol deviation                 7                 0  
Patient withdrew consent                 32                 28  
Lost to Follow-up                 8                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Aliskiren Based Treatment Regimen Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
Ramipril Based Treatment Regimen Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
Total Total of all reporting groups

Baseline Measures
    Aliskiren Based Treatment Regimen     Ramipril Based Treatment Regimen     Total  
Number of Participants  
[units: participants]
 		  457     444     901  
Age  
[units: years]
Mean ± Standard Deviation 		  72.0  ± 5.56     72.2  ± 5.62     72.1  ± 5.58  
Age, Customized  
[units: participants]
 		     
65 - 74 years     312     296     608  
75 years and older     145     148     293  
Gender  
[units: participants]
 		     
Female     235     237     472  
Male     222     207     429  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12   [ Time Frame: Baseline and Week 12 ]
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2.  Secondary:   Percentage of Patients With Cough   [ Time Frame: Weeks 12 and 36 ]
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3.  Secondary:   Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints   [ Time Frame: Weeks 12 and 36 ]
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4.  Secondary:   Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36   [ Time Frame: Baseline and week 36 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Study Director
Organization: Novaris Phamaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00368277     History of Changes
Other Study ID Numbers: CSPP100A2344
Study First Received: August 22, 2006
Results First Received: December 14, 2010
Last Updated: February 28, 2011
Health Authority: United States: Food and Drug Administration