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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:
Merck
ClinicalTrials.gov Identifier:
NCT00447603
First received: March 14, 2007
Last updated: August 31, 2012
Last verified: February 2012
History of Changes

March 14, 2007
August 31, 2012
June 2007
October 2007   (final data collection date for primary outcome measure)
Lower blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Lower blood pressure after 4 weeks of treatment.
Complete list of historical versions of study NCT00447603 on ClinicalTrials.gov Archive Site
Well tolerated in pediatric patients. [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
Well tolerated in pediatric patients.
Not Provided
Not Provided
 
A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)
A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension

The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: hydrochlorothiazide (+) losartan potassium
    losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
    Other Name: MK0954A
  • Drug: losartan potassium
    Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
    Other Name: MK0954
  • Drug: Comparator: losartan potassium
    losartan potassium 25mg titrating up to Losartan 50mg tablet po qd for a 4 week study period.
    Other Name: MK0954
  • Drug: Comparator: Placebo (unspecified)
    losartan potassium 25mg Pbo tablet po qd; 50mg Pbo tablet po qd; 100mg Pbo tablet po qd; for a 4 week study period.
  • Drug: Comparator: Placebo (unspecified)
    losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
  • 1
    Interventions:
    • Drug: Comparator: losartan potassium
    • Drug: Comparator: Placebo (unspecified)
  • 2
    Interventions:
    • Drug: losartan potassium
    • Drug: Comparator: Placebo (unspecified)
  • 3
    Interventions:
    • Drug: hydrochlorothiazide (+) losartan potassium
    • Drug: Comparator: losartan potassium
    • Drug: Comparator: Placebo (unspecified)
  • 4
    Interventions:
    • Drug: hydrochlorothiazide (+) losartan potassium
    • Drug: losartan potassium
    • Drug: Comparator: Placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure)
  • Patient is able to swallow tablets
  • Females of child bearing potential must use acceptable contraception throughout the trial

Exclusion Criteria:

  • Patient has a history of heart, metabolic or kidney disease
  • Patient has a history of known heart, lung, liver and other body system disorders
  • Patient is pregnant or nursing
  • Patient has participated in another clinical trial within the last 28 days
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00447603
MK-0954A-327, 2007_502
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP