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Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans (ATLAAST)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00739596
First received: August 21, 2008
Last updated: February 14, 2011
Last verified: February 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, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks
Drug: Amlodipine: 8 weeks

  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 Hydrochlorothiazide (HCTZ) Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
Amlodipine Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks

Participant Flow:   Overall Study
    Aliskiren Hydrochlorothiazide (HCTZ)     Amlodipine  
STARTED     166     166  
COMPLETED     141     149  
NOT COMPLETED     25     17  
Adverse Event                 12                 6  
Unsatisfactory Therapeutic Effect                 4                 0  
Patient Withdrew Consent                 8                 8  
Lost to Follow-up                 0                 2  
Protocol Deviation                 1                 1  



  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 HCTZ Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
Amlodipine Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
Total Total of all reporting groups

Baseline Measures
    Aliskiren HCTZ     Amlodipine     Total  
Number of Participants  
[units: participants]
  166     166     332  
Age  
[units: participants]
     
< 65 years     141     143     284  
≥ 65 years     25     23     48  
Age  
[units: years]
Mean ± Standard Deviation
  52.0  ± 11.27     53.1  ± 11.56     52.6  ± 11.41  
Gender  
[units: participants]
     
Female     85     91     176  
Male     81     75     156  



  Outcome Measures
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1.  Primary:   Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment   [ Time Frame: Baseline and 8 weeks ]

4.  Secondary:   Percentage of Responders After 8 Weeks of Treatment.   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants Achieving BP Control After 8 Weeks of Treatment   [ 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 by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00739596     History of Changes
Other Study ID Numbers: CSPP100AUS03
Study First Received: August 21, 2008
Results First Received: December 14, 2010
Last Updated: February 14, 2011
Health Authority: United States: Food and Drug Administration