Olmesartan Medoxomil in Diabetes Mellitus

January 19, 2010 updated by: Sankyo Pharma Gmbh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4449

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time to the first occurrence

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of cardiovascular mortality and morbidity
Time Frame: Time to occurence
Time to occurence
Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)
Time Frame: Time to occurrence
Time to occurrence
Occurrence and progression of retinopathy
Time Frame: Time to occurence
Time to occurence
Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease
Time Frame: Time to occurrence
Time to occurrence
Safety and tolerability
Time Frame: Throughout entire study
Throughout entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sankyo Pharma Gmbh

Investigators

  • Principal Investigator: Prof. Hermann Haller, MD, Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE-866/44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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