Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study - ROADMAP

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000506-52-GB
• Date of registration: 04/08/2005
• Prospective Registration: No
• Primary sponsor: Daiichi Sankyo Europe 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: 19/04/2005
• 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

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

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female Caucasian patients with Type II diabetes mellitus aged between 18 and 75 years 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 treatment for hyperlipidaemia
- HDL < 40 mg/dL (1.1 mmol/L)
- Triglycerides > 150 mg/dL (1.7 mmol/L) and < 400 mg/dL (4.5 mmol/L)
- Hypertension: sBP > or = 130 mmHg and/or dBP > or = 80 mmHg
- Obesity: BMI > or = 28 kg/sq.m
- Waist circumference: > 102 cm for men, >88 cm for women
- Smoking: more than 5 cigarettes a day
- Patients with fasting blood glucose > or = 126 mg/dL (7 mmol/L) (only for patients not receiving treatment for diabetes)
- Patients with HbA1c > or = 6.5 % (only for patients not receiving treatment for diabetes)
- Patients with normoalbuminuria at screening: < or = 35 mg albumin/g urine creatinine for women and < or = 25 mg albumin /g urine creatinine for men

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 documented renal and/or renal vascular disease
- Patients with myocardial infarction, stroke, transient ischaemic attack or myocardial revascularisation or reperfusion within the last 6 months
- Patients with ASAT and ALAT greater than twice the upper limit of the laboratory reference range. Patients with GGT greater than twice the upper limit will only be excluded if ASAT or ALAT are greater than 1.5 times the upper limits
- Patients with known allergic reaction, lack of response or contraindication to ARBs
- Patients with severe hypertension (sBP > 200 mmHg and/or dBP > 110 mmHg)
- Patients with severe heart failure: NYHA Stage 3-4
- Patients with a history of drug abuse or within the last two years, alcohol addiction
- Patients receiving ARBs or ACE inhibitors within the last 6 months
- Patients with severe hyperlipidaemia
- Patients requiring psychoactive drugs (except anti-anxiety drugs, anti-depressants and medications used for the treatment of sleeping disorders). Selective serotonin reuptake inhibitors (SSRIs) are not allowed


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

Health Condition(s) or Problem(s) studied

NIDDM (non insulin dependent diabetes mellitus)
MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

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)

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
Protein Pattern and Serum Inflammatory Markers
-effects on serum inflammatory markers in a sub-group.
-effects on urinary protein pattern in a sub-group.

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.

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.

Secondary ID(s)

2004-000506-52-CZ

SE-866/44