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Olmesartan Medoxomil in Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185159
First received: September 12, 2005
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of cardiovascular mortality and morbidity [ Time Frame: Time to occurence ] [ Designated as safety issue: No ]
  • Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]
  • Occurrence and progression of retinopathy [ Time Frame: Time to occurence ] [ Designated as safety issue: No ]
  • Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Throughout entire study ] [ Designated as safety issue: No ]

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
tablets
Placebo Comparator: 2
placebo
 Drug: Placebo Tablets
Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional 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
Study First Received: September 12, 2005
Last Updated: January 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Daiichi Sankyo Inc.:
Microalbuminuria

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

ClinicalTrials.gov processed this record on May 19, 2013