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Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus (ASTRIDE)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00787605
First received: November 5, 2008
Last updated: September 20, 2016
Last verified: May 2011
Results First Received: December 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hypertension
Diabetes Mellitus
Interventions: Drug: Amlodipine
Drug: Hydrochlorothiazide (HCTZ)
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
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Reporting Groups
  Description
Aliskiren/HCTZ Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
Amlodipine Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks

Participant Flow:   Overall Study
    Aliskiren/HCTZ   Amlodipine
STARTED   428   432 
COMPLETED   382   376 
NOT COMPLETED   46   56 
Administrative Problems                3                0 
Adverse Event                14                25 
Lost to Follow-up                3                6 
Protocol Violation                7                3 
Withdrawal by Subject                6                13 
Lack of Efficacy                13                9 



  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/HCTZ Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
Amlodipine Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
Total Total of all reporting groups

Baseline Measures
   Aliskiren/HCTZ   Amlodipine   Total 
Overall Participants Analyzed 
[Units: Participants]
 428   432   860 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (9.83)   59.8  (10.01)   59.8  (9.91) 
Gender 
[Units: Participants]
     
Female   212   209   421 
Male   216   223   439 


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

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

3.  Secondary:   Percentage of Responders   [ Time Frame: Week 8 ]

4.  Secondary:   Percentage of Patients Achieving Blood Pressure Control   [ Time Frame: after 8 weeks of treatment ]

5.  Secondary:   Biomarker Measurements   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:   Evaluate the Safety and Tolerability   [ Time Frame: after 8 weeks of treatment ]


  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



Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00787605     History of Changes
Other Study ID Numbers: CSPP100A2409
Study First Received: November 5, 2008
Results First Received: December 20, 2010
Last Updated: September 20, 2016
Health Authority: United States: Food and Drug Administration