Olmesartan Medoxomil in Diabetes Mellitus

Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Sponsors

Lead Sponsor: Sankyo Pharma Gmbh

Source Daiichi Sankyo, Inc.
Brief Summary

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

Overall Status Completed
Start Date October 2004
Completion Date July 2009
Primary Completion Date July 2009
Phase Phase 3
Study Type Interventional
Primary 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 to the first occurrence
Secondary Outcome
Measure Time Frame
Incidence of cardiovascular mortality and morbidity Time to occurence
Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) Time to occurrence
Occurrence and progression of retinopathy Time to occurence
Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease Time to occurrence
Safety and tolerability Throughout entire study
Enrollment 4449
Condition
Intervention

Intervention Type: Drug

Intervention Name: Olmesartan medoxomil

Description: tablets

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: Placebo Tablets

Description: Tablets

Arm Group Label: 2

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Prof. Hermann Haller, MD Principal Investigator Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
Location
Facility:
Location Countries

Germany

Verification Date

January 2010

Responsible Party

Name Title: Heiko Rauer

Organization: Daiichi Sankyo Europe, GmbH

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: olmesartan medoxomil

Label: 2

Type: Placebo Comparator

Description: placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov