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

September 12, 2005
January 19, 2010
October 2004
July 2009   (final data collection date for primary outcome measure)
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 ]
Time to the first occurrence of microalbuminuria
Complete list of historical versions of study NCT00185159 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Incidence of cardiovascular mortality and morbidity;
  • - Incidence of renal disease, such as worsening of renal
  • function as well as end-stage (dialysis);
  • - Occurrence and progression of retinopathy;
  • - Treatment effects on a combined endpoint of
  • cardiovascular mortality and morbidity and renal disease;
  • - Safety and tolerability
Not Provided
Not Provided
 
Olmesartan Medoxomil in Diabetes Mellitus
Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Diabetes Mellitus, Type 2
  • Cardiovascular Disease
  • Kidney Disease
  • Drug: Olmesartan medoxomil
    tablets
  • Drug: Placebo Tablets
    Tablets
  • Experimental: 1
    olmesartan medoxomil
    Intervention: Drug: Olmesartan medoxomil
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Placebo Tablets

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4449
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00185159
SE-866/44
Not Provided
Heiko Rauer, Daiichi Sankyo Europe, GmbH
Sankyo Pharma Gmbh
Not Provided
Principal Investigator: Prof. Hermann Haller, MD Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
Daiichi Sankyo Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP