Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: hydrochlorothiazide (+) losartan potassium
  • losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
• Drug: losartan potassium
  • Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
• Drug: Comparator: losartan potassium
  • losartan potassium 25mg titrating up to Losartan 50mg tablet po qd for a 4 week study period.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
• Other: 2
• Other: 3
• Other: 4

Primary Measures

• Lower blood pressure
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Well tolerated in pediatric patients.
  • Time Frame: After 4 weeks of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00447603

Study ID Number: 2007_502

ClinicalTrials.gov Identifier: NCT00447603

Health Authority: United States: Food and Drug Administration