Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (ASCENT)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00942994
First received: July 19, 2009
Last updated: May 16, 2011
Last verified: May 2011
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren/Amlodipine
Drug: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)

  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 / Amlodipine / HCTZ At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
Aliskiren / Amlodipine At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.

Participant Flow:   Overall Study
    Aliskiren / Amlodipine / HCTZ     Aliskiren / Amlodipine  
STARTED     203     209  
COMPLETED     187     190  
NOT COMPLETED     16     19  
Adverse Event                 7                 4  
Abnormal laboratory value(s)                 1                 0  
Unsatisfactory therapeutic effect                 1                 1  
Patient withdrew consent                 5                 8  
Lost to Follow-up                 1                 4  
Protocol deviation                 1                 2  



  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 / Amlodipine / HCTZ At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
Aliskiren / Amlodipine At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
Total Total of all reporting groups

Baseline Measures
    Aliskiren / Amlodipine / HCTZ     Aliskiren / Amlodipine     Total  
Number of Participants  
[units: participants]
  202     209     411  
Age [1]
[units: years]
Mean ± Standard Deviation
  55.7  ± 9.79     54.7  ± 10.19     55.2  ± 10.00  
Gender [1]
[units: participants]
     
Female     107     100     207  
Male     95     109     204  
[1] Baseline characteristics are given for Safety Set. The Safety Set included all patients who received at least one dose of double-blind trial medication. One patient was excluded from the Safety Set because the patient was withdrawn from the study without receiving any dose of study medication.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8   [ Time Frame: Baseline and week 8 ]

2.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8   [ Time Frame: Baseline and week 8 ]

3.  Secondary:   Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks   [ Time Frame: 8 weeks ]

4.  Secondary:   Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.   [ Time Frame: 8 weeks ]

5.  Other Pre-specified:   Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4   [ Time Frame: Baseline, Week 2 and Week 4 ]

6.  Other Pre-specified:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4   [ Time Frame: Baseline, Week 2 and Week 4 ]


  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


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00942994     History of Changes
Other Study ID Numbers: CSPA100AUS02
Study First Received: July 19, 2009
Results First Received: March 29, 2011
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration