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Olmesartan Medoxomil in Diabetes Mellitus

This study has been completed.
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: September 12, 2005
Last updated: January 19, 2010
Last verified: January 2010
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Cardiovascular Disease Kidney Disease Drug: Olmesartan medoxomil Drug: Placebo Tablets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine [ Time Frame: Time to the first occurrence ]

Secondary Outcome Measures:
  • Incidence of cardiovascular mortality and morbidity [ Time Frame: Time to occurence ]
  • Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) [ Time Frame: Time to occurrence ]
  • Occurrence and progression of retinopathy [ Time Frame: Time to occurence ]
  • Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease [ Time Frame: Time to occurrence ]
  • Safety and tolerability [ Time Frame: Throughout entire study ]

Enrollment: 4449
Study Start Date: October 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olmesartan medoxomil
Drug: Olmesartan medoxomil
Placebo Comparator: 2
Drug: Placebo Tablets


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
  • Presence of at least one of the following cardiovascular risk factors:

    1. total cholesterol greater than 200 mg/dL or statin treatment,
    2. High density lipoprotein (HDL) less than 40 mg/dL,
    3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,
    4. blood pressure greater than or equal to 130/80 mmHg,
    5. Body mass index (BMI) greater than 28 kg/m2,
    6. waist circumference greater than 102 cm for men and greater than 88 cm for women,
    7. smoking of more than 5 cigarettes a day;
  • Normoalbuminuria at screening

Exclusion Criteria:

  • Severe uncontrolled hyperlipidemia;
  • Documented renal and/or renal-vascular disease;
  • Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
  • History of alcohol and/or drug abuse;
  • Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
  • Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor
  Contacts and Locations
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Please refer to this study by its identifier: NCT00185159

Darmstadt, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Principal Investigator: Prof. Hermann Haller, MD Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Heiko Rauer, Daiichi Sankyo Europe, GmbH Identifier: NCT00185159     History of Changes
Other Study ID Numbers: SE-866/44
Study First Received: September 12, 2005
Last Updated: January 19, 2010

Keywords provided by Daiichi Sankyo, Inc.:

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Kidney Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017