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A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

This study has been terminated.
(A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00389519
First received: October 17, 2006
Last updated: June 6, 2012
Last verified: June 2012
Results First Received: January 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: ramipril
Drug: placebo

  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
Study was conducted from October 2006 to November 2007 at 56 international sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects entered placebo run-in prior to randomization

Reporting Groups
  Description
Placebo No text entered.
Ramipril Low Dose No text entered.
Ramipril Mid Dose No text entered.
Ramipril High Dose No text entered.

Participant Flow for 3 periods

Period 1:   Placebo Run-In
    Placebo   Ramipril Low Dose   Ramipril Mid Dose   Ramipril High Dose
STARTED   422   0   0   0 
COMPLETED   244   0   0   0 
NOT COMPLETED   178   0   0   0 
Did not meet blood pressure criteria                119                0                0                0 
Withdrawal by Subject                19                0                0                0 
Reason not specified                40                0                0                0 

Period 2:   Randomized
    Placebo   Ramipril Low Dose   Ramipril Mid Dose   Ramipril High Dose
STARTED   83   41   40   80 
COMPLETED   81   41   40   80 
NOT COMPLETED   2   0   0   0 
Did not receive study drug                2                0                0                0 

Period 3:   Treated
    Placebo   Ramipril Low Dose   Ramipril Mid Dose   Ramipril High Dose
STARTED   81   41   40   80 
COMPLETED   79   40   40   76 
NOT COMPLETED   2   1   0   4 
Adverse Event                1                0                0                2 
Reason not specified                1                1                0                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.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
Ramipril Low Dose No text entered.
Ramipril Mid Dose No text entered.
Ramipril High Dose No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ramipril Low Dose   Ramipril Mid Dose   Ramipril High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   41   40   80   242 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.2  (3.06)   12.3  (3.03)   12.1  (2.81)   12.3  (3.06)   12.2  (2.99) 
Gender 
[Units: Participants]
         
Female   32   16   11   29   88 
Male   49   25   29   51   154 
Race/Ethnicity, Customized 
[Units: Participants]
         
Black   21   11   10   20   62 
Asian   8   1   4   10   23 
Caucasian   27   15   13   29   84 
Hispanic   25   14   13   20   72 
Other   0   0   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure   [ Time Frame: Baseline to 4 weeks ]

2.  Secondary:   Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure   [ Time Frame: Baseline to 4 weeks ]

3.  Secondary:   Change From Baseline to 4 Weeks in Serum Creatinine   [ Time Frame: Baseline up to 4 weeks ]

4.  Secondary:   Change From Baseline to 4 Weeks in Serum Potassium   [ Time Frame: Baseline up to 4 weeks ]

5.  Secondary:   Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)   [ Time Frame: Baseline up to 4 weeks ]


  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
No text entered.


  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: Professional Information Services
Organization: King Pharmaceuticals, Inc.
phone: 1-800-776-3637



ClinicalTrials.gov Identifier: NCT00389519     History of Changes
Other Study ID Numbers: K726-06-4003
Study First Received: October 17, 2006
Results First Received: January 21, 2010
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
India: Ministry of Health
Poland: Ministry of Health
South Africa: Medicines Control Council
Turkey: Ministry of Health
Ukraine: Ministry of Health