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Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00654875
First received: April 3, 2008
Last updated: June 24, 2011
Last verified: June 2011
Results First Received: December 13, 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: Essential Hypertension
Interventions: Drug: Aliskiren
Drug: 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
No text entered.

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 300 mg (Once a Day) Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
Aliskiren 150 mg (Twice a Day) Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.

Participant Flow:   Overall Study
    Aliskiren 300 mg (Once a Day)     Aliskiren 150 mg (Twice a Day)  
STARTED     164     164  
COMPLETED     147     147  
NOT COMPLETED     17     17  
Adverse Event                 5                 5  
Withdrawal by Subject                 4                 4  
Protocol Violation                 3                 3  
Lack of Efficacy                 2                 2  
Lost to Follow-up                 1                 3  
Abnormal Test Procedure Result(s)                 1                 0  
Administrative Problems                 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.
No text entered.

Reporting Groups
  Description
Aliskiren 300 mg (Once a Day) Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
Aliskiren 150 mg (Twice a Day) Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
Total Total of all reporting groups

Baseline Measures
    Aliskiren 300 mg (Once a Day)     Aliskiren 150 mg (Twice a Day)     Total  
Number of Participants  
[units: participants]
  164     164     328  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 10.3     54  ± 10.2     54  ± 10.3  
Gender  
[units: participants]
     
Female     63     77     140  
Male     101     87     188  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)   [ Time Frame: Baseline, Week 6 ]

2.  Secondary:   Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period   [ Time Frame: Baseline, Week 6 ]

3.  Secondary:   Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period   [ Time Frame: Baseline, Week 6 ]

4.  Secondary:   Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)   [ Time Frame: Baseline, Week 6 ]

5.  Secondary:   Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure   [ Time Frame: Baseline, Week 6 ]

6.  Secondary:   Percentage of Participants Achieving Blood Pressure Control at Week 6   [ Time Frame: Week 6 ]

7.  Secondary:   Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)   [ Time Frame: Week 10 ]


  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: Novartis
ClinicalTrials.gov Identifier: NCT00654875     History of Changes
Other Study ID Numbers: CSPP100A2403
Study First Received: April 3, 2008
Results First Received: December 13, 2010
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines