Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAP

• Register: EUCTR
• Last refreshed on: 25 March 2013
• Main ID: EUCTR2004-000506-52-AT
• Date of registration: 08/10/2004
• Prospective Registration: Yes
• Primary sponsor: Sankyo Pharma GmbH
• Public title: Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAP
• Scientific title: Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAP
• Date of first enrolment: 22/02/2005
• Target sample size: 4400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000506-52
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Czech Republic, Estonia, Hungary, Italy, Latvia, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
-male or female patients with type II diabetes mellitus defined by the American Diabetes Association (ADA) criteria (fasting blood glucose ³ 126 mg/dL (7 mmol/L)) who have at least one of the following cardiovascular risk factors:
- Lipid disorder defined as: total cholesterol > 200 mg/dL (5.2 mmol/L) or statin treatment.
- HDL < 40 mg/dL (1.1 mmol/L).
- Triglycerides > 150 mg/dL (1.7 mmol/L) and < 400 mg/dL (4.5 mmol/L).
- blood pressure: sBP ³ 130 mmHg and dBP ³ 80 mmHg.
- obesity: BMI ³ 28 m2/kg.
- waist circumference: > 102 cm for men, >88 cm for women.
- smoking: more than 5 cigarettes a day
-normoalbuminuria at Screening less than or equal to 35 mg albumin/g urine creatinine for women and less than or equal to 25 mg albumin/g urine creatinine for men (confirmed by two independent measurements within two weeks).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- patients with severe hyperlipidaemia (high lipid values not controlled by usual treatment).- patients with documented renal and/or renal-vascular disease.
- patients with myocardial infarction (MI), stroke or myocardial revascularization within the last 6 months.
- patients with a history of drug abuse.
- patients with alcohol addiction within the last two years.
- patients with known allergic reaction, lack of response or contraindication to Ang II-antagonists.
- patients receiving angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) inhibitor (within last 6 months).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

NIDDM (non insulin dependent diabetes mellitus)
Classification code 10029402

Intervention(s)

Trade Name: Olmetec® 40mg
Product Name: Olmetec
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: olmesartan medoxomil
CAS Number: CS-866
Current Sponsor code: CS-866
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40 -
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Time to the first occurrence of microalbuminuria defined as albumin excretion in morning urine (collected as spot urine) of > 35 mg albumin/g urine creatinine for women and > 25 mg albumin/g urine creatinine for men.

Main Objective: To determine the difference in the time to event of microalbuminuria in patients receiving 40 mg olmesartan medoxomil compared to placebo using morning spot urine collections, assessed from baseline until occurrence of microalbuminuria.

Secondary Objective: To test the hypothesis that treatment with olmesartan medoxomil has a positive effect on cardiovascular and renal morbidity and mortality, as evaluated by:
Cardiovascular mortality
-sudden death and fatal MI
-fatal stroke
-combined endpoint
Cardiovascular morbidity
-coronary artery disease due to angina pectoris
-myocardial insufficiency due to heart failure
-transitory ischaemic attack, non-fatal myocardial infarction, non-fatal stroke
-peripheral vascular disease
-combined endpoint
Renal disease
-end-stage renal disease
-worsening of renal function
-combined endpoint
Retinopathy
-occurrence/progression of retinopathy
-microvascular morbidity
Analyse Subgroups
-age and date of diagnosis and prognostic factors from beginning to end
Safety and Tolerability
-safety and tolerability of treatment

Secondary ID(s)

SE-866/44