Study to Determine the Effects of Losartan on Proteinuria in Pediatric Patients (0954-326) - 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:	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, 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: High Blood Pressure Potassium 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 ]
Change from baseline in protein/creatinine ratio at Week 12 expressed as geometric mean percent change (back transformation of the log-transformed fraction from baseline)

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
Study Completion Date:	March 2011
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 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
Active Comparator: 3 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
Experimental: 4 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

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

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Webb NJ, Lam C, Shahinfar S, Strehlau J, Wells TG, Gleim GW, Le Bailly De Tilleghem C. Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. Nephrol Dial Transplant. 2011 Aug;26(8):2521-6. Epub 2011 Feb 1.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00568178 History of Changes
Other Study ID Numbers:	2006_560, MK0954-326
Study First Received:	December 3, 2007
Results First Received:	August 11, 2009
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012