A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)

This study has been terminated.
(Achieving site readiness and enrolling the trial within a reasonable time)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00447603
First received: March 14, 2007
Last updated: March 12, 2014
Last verified: March 2014
Results First Received: January 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: hydrochlorothiazide (+) losartan potassium
Drug: losartan potassium
Drug: Placebo for Losartan
Drug: Placebo for Losartan/HCTZ

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was discontinued early due to limited availability of sites and readiness of sites to enroll participants within the predefined time. Although some participants were screened and entered Filter Period, none were randomly assigned to a treatment arm and none entered double-blind treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants entered screening. If initial criteria were met, eligible participants were separated into 2 strata based on weight and administered either 25-50mg or 50-100mg Losartan during Filter Period. Participant’s whose blood pressure did not respond were eligible to be randomly assigned to the Treatment period of the study.

Reporting Groups
  Description
All Enrolled Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
Losartan 25 Mg-50 mg (Filter Period) Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
Losartan 50 Mg-100 mg (Filter Period) Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks

Participant Flow for 2 periods

Period 1:   Screening
    All Enrolled     Losartan 25 Mg-50 mg (Filter Period)     Losartan 50 Mg-100 mg (Filter Period)  
STARTED     40     0     0  
COMPLETED     19     0     0  
NOT COMPLETED     21     0     0  
Withdrawal by Subject                 1                 0                 0  
Protocol Violation                 1                 0                 0  
Screen Failure                 4                 0                 0  
Study Terminated by Sponsor                 15                 0                 0  

Period 2:   Filter Period
    All Enrolled     Losartan 25 Mg-50 mg (Filter Period)     Losartan 50 Mg-100 mg (Filter Period)  
STARTED     0     4 [1]   15 [1]
COMPLETED     0     0     0  
NOT COMPLETED     0     4     15  
Adverse Event                 0                 0                 1  
Screen Failure                 0                 3                 4  
Study terminated by Sponsor                 0                 1                 10  
[1] The study was discontinued early; no participant entered treatment period



  Baseline Characteristics
  Hide Baseline Characteristics

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.
All enrolled population which included all participants who provided consent and entered screening period of study.

Reporting Groups
  Description
All Enrolled Participants who met initial screening criteria for inclusion in study and were enrolled in the study.

Baseline Measures
    All Enrolled  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Mean ± Standard Deviation
  13.7  ± 2.58  
Gender  
[units: Participants]
 
Female     9  
Male     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study   [ Time Frame: up to 4 weeks ]

3.  Primary:   Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study   [ Time Frame: up to 4 weeks ]

4.  Secondary:   Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period   [ Time Frame: Baseline and Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
The study was discontinued early (during screening) due to limited availability of sites and readiness of sites to enroll participants within the predefined time.  


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: NCT00447603     History of Changes
Other Study ID Numbers: 0954A-327, 2007_502
Study First Received: March 14, 2007
Results First Received: January 23, 2014
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration