Study to Determine the Effects of Losartan on Proteinuria in Pediatric Patients - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00568178

Purpose

The purpose of this study is to evaluate the effects of Losartan on proteinuria (protein amounts in the urine) in pediatric patients.

Condition	Intervention	Phase
Proteinuria	Drug: Comparator: losartan potassium Drug: Comparator: Placebo to amlodipine Drug: Comparator: amlodipine besylate Drug: Comparator: Placebo to losartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Amlodipine Amlodipine besylate Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in Protein/Creatinine (Pr/Cr) Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Systolic Blood Pressure in Hypertensive Patients at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in Diastolic Blood Pressure in Hypertensive Patients at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment:	306
Study Start Date:	May 2007
Estimated Study Completion Date:	February 2011
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: Normotensive patients: Losartan	Drug: Comparator: losartan potassium losartan potassium 25 and 50 milligram (mg) tablets or suspension. Dose will titrate up to a maximum of 100mg (based on weight) orally per day (po qd).Duration of Treatment: 12 Weeks
2: Placebo Comparator Arm 2: Normotensive patients: Placebo to Losartan	Drug: Comparator: Placebo to losartan losartan potassium 25 and 50 mg placebo tablets or suspension po qd. Duration of Treatment: 12 Weeks
3: Active Comparator Arm 3: Hypertensive patients: Amlodipine + Placebo to Losartan	Drug: Comparator: amlodipine besylate amlodipine besylate 0.05 mg/kg suspension (maximum 5mg/day.Duration of Treatment: 12 Weeks Drug: Comparator: Placebo to losartan losartan potassium 25 and 50 mg placebo tablets or suspension po qd. Duration of Treatment: 12 Weeks
4: Experimental Arm 4: Hypertensive patients: Losartan + Placebo to Amlodipine	Drug: Comparator: losartan potassium losartan potassium 25 and 50 milligram (mg) tablets or suspension. Dose will titrate up to a maximum of 100mg (based on weight) orally per day (po qd).Duration of Treatment: 12 Weeks Drug: Comparator: Placebo to amlodipine amlodipine besylate Placebo suspension 0.05 mg/kilogram (kg) (maximum 5mg/day).Duration of Treatment: 12 Weeks

Detailed Description:

This is a 12-week double-blind study with an optional open-label extension phase. Patients who completed or discontinued the 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension will continue until the 100th patient completes 3 years of follow-up.

Eligibility

Ages Eligible for Study:	1 Year to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient 1 to 17 years of age; Patient is able to provide a first morning urine sample
Patient has documented history of proteinuria associated with chronic kidney disease of any origin
A parent or legal guardian will need to sign a consent form
The child may also be asked to sign a consent form, depending on his/her age

Exclusion Criteria:

Patient is pregnant or nursing; Patients who needs more than 2 medications to control their high blood pressure
Patient has nephrotic-range proteinuria that is steroid responsive
Patient has undergone major organ transplantation (e.g. heart, kidney, liver)
Patient has a known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
Patient has a known sensitivity to amlodipine or other calcium channel blocker
Patient requires cyclosporine to treat renal disease
Patient has any reason to think that they would not be cooperative, take study drug as asked, or not keep appointments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568178

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_560, MK0954-326
Study First Received:	December 3, 2007
Results First Received:	August 11, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00568178 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Therapeutic Uses
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 08, 2010