DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: losartan potassium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Clinical Details

Official title: A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Change From Baseline in Systolic Blood Pressure

Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)

Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event

Secondary outcome: Mean Change From Baseline in Diastolic Blood Pressure

Eligibility

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant is determined to be hypertensive

Exclusion Criteria:

- Participant has a history of severe or symptomatic hypertension

- Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or

obstructive valvular disease

- Participant has started taking hypertensive medications within the past 30 days

- Participant has a known sensitivity to losartan or history of angioneurotic edema

Locations and Contacts

Additional Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: March 2009
Last updated: January 14, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017