Olmesartan Medoxomil in Diabetes Mellitus - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 19, 2010

Start Date ^ICMJE

October 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Time to the first occurrence of microalbuminuria

Change History

Complete list of historical versions of study NCT00185159 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

- 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

Descriptive Information

Brief Title ^ICMJE

Olmesartan Medoxomil in Diabetes Mellitus

Official Title ^ICMJE

Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus, Type 2
Cardiovascular Disease
Kidney Disease

Intervention ^ICMJE

Drug: Olmesartan medoxomil
tablets
Drug: Placebo Tablets
Tablets

Study Arms

Experimental: 1
olmesartan medoxomil

Intervention: Drug: Olmesartan medoxomil
Placebo Comparator: 2
placebo

Intervention: Drug: Placebo Tablets

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4449

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00185159

Other Study ID Numbers ^ICMJE

SE-866/44

Has Data Monitoring Committee

Responsible Party

Heiko Rauer, Daiichi Sankyo Europe, GmbH

Study Sponsor ^ICMJE

Sankyo Pharma Gmbh

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Prof. Hermann Haller, MD

Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany

Information Provided By

Daiichi Sankyo Inc.

Verification Date

January 2010

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