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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
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 |