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A Research Study to Evaluate the Renal (Kidney) Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes (0954-147)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00308347
First received: March 27, 2006
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Evaluate the effect of Losartan in reducing kidney disease in patients with Non-insulin Dependent Diabetes and Nephropathy (kidney damage that usually accompanies late stage Diabetes Mellitus).


Condition Intervention Phase
Type 2 Diabetes
Nephropathy
Drug: MK0954, losartan / Duration of Treatment: mean 3.4 years
Drug: Placebo / Duration of Treatment: mean 3.4 years
Phase 3

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 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Non-insulin Dependent Diabetes Mellitus and Nephropathy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Combined endpoint of doubling of serum creatinine, ESRD or death.

Secondary Outcome Measures:
  • Secondary parameters: number of cardiovascular events and changes in proteinuria. Tertiary parameters: quality of life and healthcare resource utilization.

Estimated Enrollment: 1513
Study Start Date: June 1996
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   31 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes diagnosed after the age of 30
  • Insulin not required within 6 months of first being diagnosed with Non-insulin Dependent Diabetes Mellitus
  • No history of diabetic ketoacidosis
  • Patients may be currently treated with diet, oral hypoglycemics or insulin
  • Patients must have proteinuria defined as: Urine protein >1+ on dipstick at the initial screening visit
  • Patients with hypertension (high blood pressure) must have a sitting blood pressure >200/110 mm Hg at Visit 1

Exclusion Criteria:

  • Patients with insulin-dependent diabetes mellitus (juvenile onset)
  • Patients treated with an ACE inhibitor or angiotensin II antagonist (AIIA) for >5 years
  • Patients treated with ACE inhibitor or AIIA therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization
  • History of myocardial infarction (MI) (heart attack) or coronary artery bypass graft (CABG) surgery within the past 1 month
  • History of cerebral vascular accident (CVA) (stroke) or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
  • History of transient ischemic attacks (TIA) within the past year. Patients with unstable angina are excluded until stabilized
  • Heart failure requiring ACE inhibitor therapy
  • Steroids (oral or parenteral) or immunosuppressives are not permitted. Debilitating psychological illness
  • Evidence of significant hepatic (liver) dysfunction: History of allergy to losartan
  • Known positive test for HIV or patients known to be hepatitis B or C antigen carriers
  • Pregnant or nursing women
  • Females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization
  • Pregnancy tests will be done every 3 months during the study and at the time of discontinuation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308347

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00308347     History of Changes
Other Study ID Numbers: 2006_020, MK0954-147
Study First Received: March 27, 2006
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014