Back to resultsOlmesartan Medoxomil in Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2, Cardiovascular Disease, Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olmesartan medoxomil
Placebo Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Microalbuminuria
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: total cholesterol greater than 200 mg/dL or statin treatment, High density lipoprotein (HDL) less than 40 mg/dL, triglycerides greater than 150 mg/dL and less than 400 mg/dL, blood pressure greater than or equal to 130/80 mmHg, Body mass index (BMI) greater than 28 kg/m2, waist circumference greater than 102 cm for men and greater than 88 cm for women, 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
olmesartan medoxomil
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00185159
First Posted
September 12, 2005
Last Updated
January 19, 2010
Sponsor
Sankyo Pharma Gmbh
1. Study Identification
Unique Protocol Identification Number
NCT00185159
Brief Title
Olmesartan Medoxomil in Diabetes Mellitus
Official Title
Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sankyo Pharma Gmbh
4. Oversight
5. Study Description
Brief Summary
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Disease, Kidney Disease
Keywords
Microalbuminuria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4449 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoxomil
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of cardiovascular mortality and morbidity
Time Frame
Time to occurence
Title
Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)
Time Frame
Time to occurrence
Title
Occurrence and progression of retinopathy
Time Frame
Time to occurence
Title
Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease
Time Frame
Time to occurrence
Title
Safety and tolerability
Time Frame
Throughout entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
total cholesterol greater than 200 mg/dL or statin treatment,
High density lipoprotein (HDL) less than 40 mg/dL,
triglycerides greater than 150 mg/dL and less than 400 mg/dL,
blood pressure greater than or equal to 130/80 mmHg,
Body mass index (BMI) greater than 28 kg/m2,
waist circumference greater than 102 cm for men and greater than 88 cm for women,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Hermann Haller, MD
Organizational Affiliation
Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
Official's Role
Principal Investigator
Facility Information:
City
Darmstadt
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29035939
Citation
Chatzikyrkou C, Menne J, Izzo J, Viberti G, Rabelink T, Ruilope LM, Rump C, Mertens PR, Haller H. Predictors for the development of microalbuminuria and interaction with renal function. J Hypertens. 2017 Dec;35(12):2501-2509. doi: 10.1097/HJH.0000000000001491.
Results Reference
derived
PubMed Identifier
24772521
Citation
Menne J, Ritz E, Ruilope LM, Chatzikyrkou C, Viberti G, Haller H. The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation. J Am Heart Assoc. 2014;3(2):e000810. doi: 10.1161/jaha.114.000810.
Results Reference
derived
PubMed Identifier
22418908
Citation
Menne J, Izzo JL Jr, Ito S, Januszewicz A, Katayama S, Chatzykirkou C, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G, Haller H; ROADMAP investigators. Prevention of microalbuminuria in patients with type 2 diabetes and hypertension. J Hypertens. 2012 Apr;30(4):811-8; discussion 818. doi: 10.1097/HJH.0b013e328351856d. Erratum In: J Hypertens. 2012 Aug;30(8):1679.
Results Reference
derived
PubMed Identifier
21388309
Citation
Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.
Results Reference
derived
PubMed Identifier
21150933
Citation
Januszewicz A, Ritz E, Viberti G, Mimran A, Rabelink AJ, Rump LC, Ruilope LM, Katayama S, Ito S, Izzo JL Jr, Haller H. Office and ambulatory pulse pressure--association with clinical characteristics and cardiovascular risk factors in normoalbuminuric patients with type 2 diabetes (ROADMAP study). J Hum Hypertens. 2011 Nov;25(11):679-85. doi: 10.1038/jhh.2010.111. Epub 2010 Dec 9.
Results Reference
derived
PubMed Identifier
19876613
Citation
Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H. Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study. Diabetologia. 2010 Jan;53(1):49-57. doi: 10.1007/s00125-009-1577-3. Epub 2009 Oct 30.
Results Reference
derived
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Olmesartan Medoxomil in Diabetes Mellitus
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