Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (AIMS)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00797316
First received: November 24, 2008
Last updated: March 8, 2011
Last verified: March 2011
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: Hydrochlorothiazide

  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
No text entered.

Reporting Groups
  Description
Aliskiren/HCTZ Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
Aliskiren Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.

Participant Flow:   Overall Study
    Aliskiren/HCTZ     Aliskiren  
STARTED     267     265  
COMPLETED     244     233  
NOT COMPLETED     23     32  
Administrative problems                 1                 0  
Adverse Event                 5                 3  
Lost to Follow-up                 4                 8  
Protocol Deviation                 1                 2  
Patient withdrew consent                 12                 6  
Unsatisfactory therapeutic effect                 0                 13  



  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.
No text entered.

Reporting Groups
  Description
Aliskiren/HCTZ Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
Aliskiren Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Total Total of all reporting groups

Baseline Measures
    Aliskiren/HCTZ     Aliskiren     Total  
Number of Participants  
[units: participants]
  267     265     532  
Age  
[units: years]
Mean ± Standard Deviation
  54.4  ± 11.09     53.5  ± 10.87     53.9  ± 10.98  
Age, Customized  
[units: participants]
     
< 65     217     233     450  
>= 65     50     32     82  
Gender  
[units: participants]
     
Female     128     129     257  
Male     139     136     275  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: 8 weeks ]

3.  Secondary:   Percentage of Participants With Blood Pressure Response at Week 8   [ Time Frame: 8 weeks ]

4.  Secondary:   Percentage of Patients Achieving Blood Pressure Control at Week 8   [ Time Frame: 8 weeks ]

5.  Secondary:   Change From Baseline to Week 8 in Pulse Pressure   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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: NCT00797316     History of Changes
Other Study ID Numbers: CSPP100A2410
Study First Received: November 24, 2008
Results First Received: December 14, 2010
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration