A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00631917
First received: March 3, 2008
Last updated: June 30, 2011
Last verified: June 2011
Results First Received: January 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren
Drug: Ramipril
Other: Placebo to Ramipril
Other: Placebo to Aliskiren

  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 For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
Ramipril For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.

Participant Flow:   Overall Study
    Aliskiren     Ramipril  
STARTED     375     399  
COMPLETED     287     291  
NOT COMPLETED     88     108  
Adverse Event                 34                 45  
Abnormal laboratory value(s)                 2                 1  
Abnormal test procedure result(s)                 3                 2  
Unsatisfactory therapeutic effect                 8                 14  
No longer required study drug                 0                 1  
Protocol deviation                 6                 5  
Subject withdrew consent                 25                 33  
Lost to Follow-up                 7                 7  
Administrative problems                 2                 0  
Death                 1                 0  



  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 For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
Ramipril For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
Total Total of all reporting groups

Baseline Measures
    Aliskiren     Ramipril     Total  
Number of Participants  
[units: participants]
  375     399     774  
Age  
[units: years]
Mean ± Standard Deviation
  59.3  ± 6.99     59.3  ± 6.65     59.3  ± 6.81  
Age, Customized  
[units: Participants]
     
< 65 years     299     313     612  
65 years and greater     76     86     162  
Gender  
[units: participants]
     
Female     194     194     388  
Male     181     205     386  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Colonic Pathology   [ Time Frame: 54 weeks ]

2.  Primary:   Summary of the End of Study Colonoscopy Results   [ Time Frame: 54 weeks ]

3.  Secondary:   Percentage of Participants With Each of the Individual Components of Colonic Pathology   [ Time Frame: 54 weeks ]

4.  Secondary:   Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment   [ Time Frame: 54 weeks ]

5.  Secondary:   Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target   [ Time Frame: Weeks 8, 30 and End of Study (54 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: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00631917     History of Changes
Other Study ID Numbers: CSPP100A2404
Study First Received: March 3, 2008
Results First Received: January 5, 2011
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration