NCT00185159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,449

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

4.8 years

First QC Date

September 12, 2005

Last Update Submit

January 19, 2010

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseaseKidney Disease

Keywords

Microalbuminuria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL

olmesartan medoxomil

Drug: Olmesartan medoxomil

2

PLACEBO COMPARATOR

placebo

Drug: Placebo Tablets

Interventions

Olmesartan medoxomilDRUG

tablets

1
Placebo TabletsDRUG

Tablets

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Darmstadt, Germany

Location

Related Publications (7)

  • Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.

    PMID: 36975019DERIVED

  • 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.

    PMID: 29035939DERIVED

  • 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.

    PMID: 24772521DERIVED

  • 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.

    PMID: 22418908DERIVED

  • 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.

    PMID: 21388309DERIVED

  • 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.

    PMID: 21150933DERIVED

  • 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.

    PMID: 19876613DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesKidney Diseases

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Prof. Hermann Haller, MD

    Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

DE(1)