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Completed

NCT Number: NCT00185159

Olmesartan Medoxomil in Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • total cholesterol greater than 200 mg/dL or statin treatment,
  • High density lipoprotein (HDL) less than 40 mg/dL,
  • triglycerides greater than 150 mg/dL and less than 400 mg/dL,
  • blood pressure greater than or equal to 130/80 mmHg,
  • Body mass index (BMI) greater than 28 kg/m2,
  • waist circumference greater than 102 cm for men and greater than 88 cm for women,
  • 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

Treatment and study plan

olmesartan medoxomil

Drug

tablets

Placebo tablets

Drug

Tablets

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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