Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00756938
First received: September 18, 2008
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: January 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: losartan potassium

  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
Losartan Potassium 0.1 to 1.4 mg/kg Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Losartan Potassium 0.3 to 1.4 mg/kg Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
Losartan Potassium 0.7 to 1.4 mg/kg Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Losartan Potassium-Extension Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study

Participant Flow for 2 periods

Period 1:   12-week Base Study
    Losartan Potassium 0.1 to 1.4 mg/kg     Losartan Potassium 0.3 to 1.4 mg/kg     Losartan Potassium 0.7 to 1.4 mg/kg     Losartan Potassium-Extension  
STARTED     33     34     34     0  
COMPLETED     31     34     32     0  
NOT COMPLETED     2     0     2     0  
Protocol-specific Criteria Met                 1                 0                 1                 0  
Protocol Violation                 0                 0                 1                 0  
Lost to Follow-up                 1                 0                 0                 0  

Period 2:   Optional Extension
    Losartan Potassium 0.1 to 1.4 mg/kg     Losartan Potassium 0.3 to 1.4 mg/kg     Losartan Potassium 0.7 to 1.4 mg/kg     Losartan Potassium-Extension  
STARTED     0     0     0     90 [1]
COMPLETED     0     0     0     53  
NOT COMPLETED     0     0     0     37  
Lack of Efficacy                 0                 0                 0                 1  
End of Study                 0                 0                 0                 11  
Protocol-specific criteria met                 0                 0                 0                 9  
Physician Decision                 0                 0                 0                 3  
Lost to Follow-up                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 0                 10  
Adverse Event                 0                 0                 0                 1  
[1] 7 participants who completed base study opted not to enter extension



  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
Losartan Potassium 0.1 to 1.4 mg/kg Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Losartan Potassium 0.3 to 1.4 mg/kg Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
Losartan Potassium 0.7 to 1.4 mg/kg Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Total Total of all reporting groups

Baseline Measures
    Losartan Potassium 0.1 to 1.4 mg/kg     Losartan Potassium 0.3 to 1.4 mg/kg     Losartan Potassium 0.7 to 1.4 mg/kg     Total  
Number of Participants  
[units: participants]
  33     34     34     101  
Age  
[units: Months]
Mean ± Standard Deviation
  40.2  ± 24.4     45.0  ± 21.5     40.6  ± 21.2     42.0  ± 22.3  
Gender  
[units: Participants]
       
Female     13     16     14     43  
Male     20     18     20     58  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Systolic Blood Pressure   [ Time Frame: Baseline and Day 21 ]

2.  Primary:   Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)   [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ]

3.  Primary:   Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event   [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ]

4.  Secondary:   Mean Change From Baseline in Diastolic Blood Pressure   [ Time Frame: Baseline and Day 21 ]


  Serious Adverse Events


  Other Adverse Events


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00756938     History of Changes
Other Study ID Numbers: 0954-337, 2008_545, CTRI/2009/091/000045
Study First Received: September 18, 2008
Results First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration