Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00841672
First received: February 10, 2009
Last updated: July 5, 2011
Last verified: July 2011
Results First Received: January 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Moderate to Severe Hypertension
Interventions: Drug: Aliskiren/amlodipine 300/10 mg tablet
Drug: Amlodipine 10 mg capsule

  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/Amlodipine 300/10 mg Tablet Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
Amlodipine 10 mg Capsule Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.

Participant Flow:   Overall Study
    Aliskiren/Amlodipine 300/10 mg Tablet     Amlodipine 10 mg Capsule  
STARTED     244 [1]   241  
COMPLETED     224     209  
NOT COMPLETED     20     32  
Adverse Event                 7                 16  
Abnormal test procedure result(s)                 0                 1  
Subject withdrew consent                 2                 4  
Lost to Follow-up                 1                 1  
Administrative problems                 9                 9  
Misrandomized                 1                 0  
Protocol Deviation                 0                 1  
[1] One patient was mis-randomized and was not treated in the double-blind treatment period.



  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/Amlodipine 300/10 mg Tablet Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
Amlodipine 10 mg Capsule Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
Total Total of all reporting groups

Baseline Measures
    Aliskiren/Amlodipine 300/10 mg Tablet     Amlodipine 10 mg Capsule     Total  
Number of Participants  
[units: participants]
  244     241     485  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 10.38     59  ± 10.82     59  ± 10.60  
Gender  
[units: participants]
     
Female     136     139     275  
Male     108     102     210  



  Outcome Measures
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1.  Primary:   Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: Baseline to end of study (Week 8) ]

2.  Secondary:   Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: Baseline to end of study (Week 8) ]

3.  Secondary:   Systolic Blood Pressure Response   [ Time Frame: Baseline to end of study (Week 8) ]

4.  Secondary:   Diastolic Blood Pressure Response   [ Time Frame: Baseline to end of study (Week 8) ]

5.  Secondary:   Blood Pressure Control   [ Time Frame: End of study (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: NCT00841672     History of Changes
Other Study ID Numbers: CSPA100A2306
Study First Received: February 10, 2009
Results First Received: January 5, 2011
Last Updated: July 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Philippines: Bureau of Food and Drugs
Spain: Spanish Agency of Medicines
Romania: National Medicines Agency