Back to resultsAntiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)
Primary Purpose
Renal Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0954, losartan potassium/Duration of Treatment: 20 weeks
Comparator: amlodipine / Duration of Treatment: 20 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Renal Disorder
Eligibility Criteria
Inclusion Criteria: Males or females at least 18 years of age with non-diabetic proteinuric renal diseases
Sites / Locations
Outcomes
Primary Outcome Measures
24h proteinuria
Secondary Outcome Measures
Changes in the plasma and urinary levels of TGF-beta
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140985
Brief Title
Antiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)
Official Title
A Randomized, Parallel, Double Blind Study of Losartan Versus Amlodipine in Patients With Mild to Moderate Hypertension and Chronic Nondiabetic Proteinuric Nephropathy: Evaluation of the Effect on Proteinuria and on the Plasmatic Levels of Growth Factors (TGFß and VEGF)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954, losartan potassium/Duration of Treatment: 20 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: amlodipine / Duration of Treatment: 20 weeks
Primary Outcome Measure Information:
Title
24h proteinuria
Secondary Outcome Measure Information:
Title
Changes in the plasma and urinary levels of TGF-beta
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females at least 18 years of age with non-diabetic proteinuric renal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
12937228
Citation
Praga M, Andrade CF, Luno J, Arias M, Poveda R, Mora J, Prat MV, Rivera F, Galceran JM, Ara JM, Aguirre R, Bernis C, Marin R, Campistol JM. Antiproteinuric efficacy of losartan in comparison with amlodipine in non-diabetic proteinuric renal diseases: a double-blind, randomized clinical trial. Nephrol Dial Transplant. 2003 Sep;18(9):1806-13. doi: 10.1093/ndt/gfg284.
Results Reference
result
Learn more about this trial
Antiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)
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