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Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension (ACCELERATE)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00797862
First received: November 24, 2008
Last updated: October 7, 2011
Last verified: June 2011
History of Changes
Results First Received: April 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Hypertension
Interventions: Drug: Amlodipine
Drug: hydrochlorothiazide
Drug: 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
A 2-4 week single-blind placebo run in. 7 patients were assigned a randomization number in error (3 each in the aliskiren/amlodipine initial treatment and aliskiren based add-on regimens and 1 in the amlodipine based add-on regimen). These patients did not take any double-blind study medication and were excluded from the Full Analysis Set (FAS).

Reporting Groups
  Description
Aliskiren+Amlodipine Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Aliskiren Start-Amlodipine Add On Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Amlodipine Start-Aliskiren Add On Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.

Participant Flow:   Overall Study
    Aliskiren+Amlodipine     Aliskiren Start-Amlodipine Add On     Amlodipine Start-Aliskiren Add On  
STARTED     620 [1]   318 [2]   316 [3]
Entered Double-Blind Treatment (FAS)     617     315     315  
COMPLETED     496     250     230  
NOT COMPLETED     124     68     86  
Adverse Event                 86                 44                 58  
Abnormal Test Procedure Result                 0                 1                 1  
Lack of Efficacy                 1                 7                 6  
No longer required study medication                 1                 0                 0  
Withdrawal by Subject                 14                 7                 7  
Lost to Follow-up                 11                 0                 5  
Administrative Problem                 4                 0                 0  
Protocol Violation                 4                 6                 8  
Mis-randomized                 3                 3                 1  
[1] 3 participants were mis-randomized and discontinued. Only 617 participants received study drug.
[2] 3 participants were mis-randomized and discontinued. Only 315 participants received study drug.
[3] 1 participant was mis-randomized and discontinued. Only 315 participants received study drug.



  Baseline Characteristics
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Reporting Groups
  Description
Aliskiren+Amlodipine Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Aliskiren Start-Amlodipine Add On Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Amlodipine Start-Aliskiren Add On Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
Total Total of all reporting groups

Baseline Measures
    Aliskiren+Amlodipine     Aliskiren Start-Amlodipine Add On     Amlodipine Start-Aliskiren Add On     Total  
Number of Participants  
[units: participants]
 		  620     318     316     1254  
Age  
[units: years]
Mean ± Standard Deviation 		  58.1  ± 10.81     58.4  ± 10.83     58.1  ± 10.93     58.1  ± 10.84  
Gender  
[units: participants]
 		       
Female     305     154     160     619  
Male     315     164     156     635  



  Outcome Measures
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1.  Primary:   Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks   [ Time Frame: Baseline, 8 weeks, 16 weeks, and 24 weeks ]
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2.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24   [ Time Frame: Baseline to 24 weeks ]
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3.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32   [ Time Frame: Baseline to 32 weeks ]
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4.  Secondary:   Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks   [ Time Frame: Baseline, 8 weeks, 16 weeks and 24 weeks ]
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5.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24   [ Time Frame: Baseline to 24 weeks ]
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6.  Secondary:   Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints   [ Time Frame: Baseline to week 8, 16, 24 and 32 endpoints ]
  Show Outcome Measure 6

7.  Post-Hoc:   Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32   [ Time Frame: Baseline to 32 weeks ]
  Show Outcome Measure 7


  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
No text entered.  


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 Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00797862     History of Changes
Other Study ID Numbers: CSPA100A2307
Study First Received: November 24, 2008
Results First Received: April 21, 2011
Last Updated: October 7, 2011
Health Authority: Canada: Health Canada
Costa Rica: Ministry of Health Costa Rica
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Greece: National Organization of Medicines
South Africa: Medicines Control Council
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Venezuela: Ministry of Health and Social Development