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Study Results
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Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension (AMAZING)
This study has been completed.
Study NCT00867490   Information provided by Novartis

First Received on March 20, 2009.   Last Updated on May 4, 2011   History of Changes
Results First Received: January 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Candesartan+HCTZ - Phase 1
Drug: Aliskiren+HCTZ - Phase 2
Drug: Aliskiren+HCTZ+amlodipine - Phase 3

  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
Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine 4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.

Participant Flow for 3 periods

 Period 1:   Phase 1 - Candesartan+HCTZ
    Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine  
STARTED     186  
COMPLETED     176  
NOT COMPLETED     10  
Adverse Event                 5  
Withdrawal by Subject                 4  
Administrative Problems                 1  

Period 2:   Phase 2 - Aliskiren+HCTZ
    Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine  
STARTED     123 [1]
COMPLETED     120  
NOT COMPLETED     3  
Adverse Event                 2  
Withdrawal by Subject                 1  
[1] Only patients with mean sitting diastolic BP ≥ 90 mmHg at the end of Phase 1 entered this phase.

Period 3:   Phase 3 - Aliskiren+HCTZ+Amlodipine
    Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine  
STARTED     61 [1]
COMPLETED     61  
NOT COMPLETED     0  
[1] The first 60 patients with systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg entered this phase.



  Baseline Characteristics
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Reporting Groups
  Description
Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine 4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.

Baseline Measures
    Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine  
Number of Participants  
[units: participants]
 		  186  
Age  
[units: years]
Mean ± Standard Deviation 		 
Phase I - Candesartan+HCTZ     56.2  ± 10.62  
Phase II - Aliskiren+HCTZ     57.4  ± 10.87  
Phase III - Aliskiren+HCTZ+amlodipine     58.9  ± 10.31  
Gender, Customized [1]
[units: Participants]
 		 
Phase I - Candesartan+HCTZ     78  
Phase II - Aliskiren+HCTZ     48  
Phase III - Aliskiren+HCTZ+amlodipine     24  
Gender, Customized [2]
[units: Participants]
 		 
Phase I - Candesartan+HCTZ     108  
Phase II - Aliskiren+HCTZ     75  
Phase III - Aliskiren+HCTZ+amlodipine     37  
[1] Female
[2] Male



  Outcome Measures
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1.  Primary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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2.  Primary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
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3.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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4.  Secondary:   Change in Sitting Pulse Pressure During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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5.  Secondary:   Change in Sitting Pulse Rate During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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6.  Secondary:   Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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7.  Secondary:   Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study   [ Time Frame: Baseline Phase 2 to end of Phase 2 ]
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8.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
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9.  Secondary:   Change in Sitting Pulse Pressure During the Extension Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
  Show Outcome Measure 9

10.  Secondary:   Change in Sitting Pulse Rate During the Extension Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
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11.  Secondary:   Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study   [ Time Frame: Baseline Phase 3 to end of Phase 3 ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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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.


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
The Phases of this study were entered in separate tables for outcomes and the Phases for SAEs and the AEs were entered all in one table.  


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:
Schweizer J, Ulmer HJ, Benduhn H, Klebs S. Efficacy and tolerability of aliskiren 300 ?mg/hydrochlorothiazide 25 ?mg (± amlodipine 5? mg) in hypertensive patients not controlled by candesartan 32 ?mg plus HCT 25? mg. Curr Med Res Opin. 2011 Jan;27(1):131-40. Epub 2010 Nov 30.


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00867490     History of Changes
Other Study ID Numbers: CSPH100ADE01
Study First Received: March 20, 2009
Results First Received: January 7, 2011
Last Updated: May 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices





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