Olmesartan Medoxomil in Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185159
• Other study ID #: SE-866/44
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 19, 2010
• Start date: October 2004
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4449
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Disease
• Kidney Diseases

Intervention

Drug:
• Olmesartan medoxomil
tablets
• Placebo Tablets
Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of cardiovascular mortality and morbidity		Time to occurence	No
Secondary	Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)		Time to occurrence	No
Secondary	Occurrence and progression of retinopathy		Time to occurence	No
Secondary	Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease		Time to occurrence	No
Secondary	Safety and tolerability		Throughout entire study	No