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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
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: hydrochlorothiazide (+) losartan potassium
Drug: losartan potassium
Drug: Comparator: losartan potassium
Drug: Comparator: Placebo (unspecified)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Lower blood pressure [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Well tolerated in pediatric patients. [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
2 Drug: losartan potassium
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
Other Name: MK0954
Drug: Comparator: Placebo (unspecified)
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
3 Drug: hydrochlorothiazide (+) losartan potassium
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
Other Name: MK0954A
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.
4 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: 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.

Detailed Description:

40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447603

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00447603     History of Changes
Other Study ID Numbers: MK-0954A-327, 2007_502
Study First Received: March 14, 2007
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013