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Olmesartan Medoxomil in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00185159
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Study Start Date : October 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
olmesartan medoxomil
Drug: Olmesartan medoxomil
tablets
Placebo Comparator: 2
placebo
Drug: Placebo Tablets
Tablets



Primary Outcome Measures :
  1. 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 :
  1. Incidence of cardiovascular mortality and morbidity [ Time Frame: Time to occurence ]
  2. Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) [ Time Frame: Time to occurrence ]
  3. Occurrence and progression of retinopathy [ Time Frame: Time to occurence ]
  4. Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease [ Time Frame: Time to occurrence ]
  5. Safety and tolerability [ Time Frame: Throughout entire study ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185159


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

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

Responsible Party: Heiko Rauer, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00185159     History of Changes
Other Study ID Numbers: SE-866/44
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by Daiichi Sankyo, Inc.:
Microalbuminuria

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