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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	3 December 2012
Main ID:	EUCTR2004-000506-52-IT
Date of registration:	09/06/2005
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:	03/05/2005
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 Number of treatment arms in the trial: 2
Phase:

Countries of recruitment
Czech Republic	Estonia	Hungary	Italy	Latvia	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Prevention of microalbuminuria in patients with diabetes type II and at least one cardiovascular risk
MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Trade Name: Olmetec
Pharmaceutical Form: Coated tablet
INN or Proposed INN: olmesartan medoxomil
CAS Number: 144689-63-4
Current Sponsor code: CS-866
Concentration unit: mg milligram(s)
Concentration number: 40-

Primary Outcome(s)

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Secondary Outcome(s)

Secondary ID(s)

2004-000506-52-CZ

SE-866/44

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
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