Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Olmesartan Medoxomil in Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Germany
Darmstadt, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
Investigators
Layout table for investigator information
Principal Investigator: Prof. Hermann Haller, MD Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Heiko Rauer, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00185159    
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:
Layout table for MeSH terms
Kidney Diseases
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action