A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

March 14, 2007

Last Updated Date

September 18, 2008

Start Date ^ICMJE

April 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Lower blood pressure after 4 weeks of treatment.

Change History

Complete list of historical versions of study NCT00447603 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Well tolerated in pediatric patients.

Descriptive Information

Brief Title ^ICMJE

A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: hydrochlorothiazide (+) losartan potassium
Drug: losartan potassium
Drug: Comparator: losartan potassium
Drug: Comparator: Placebo (unspecified)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

600

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00447603

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_502, MK0954A-327

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2008

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