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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00185159
Other study ID # SE-866/44
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 19, 2010
Start date October 2004
Est. completion date July 2009

Study information

Verified date January 2010
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 4449
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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:

1. total cholesterol greater than 200 mg/dL or statin treatment,

2. High density lipoprotein (HDL) less than 40 mg/dL,

3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,

4. blood pressure greater than or equal to 130/80 mmHg,

5. Body mass index (BMI) greater than 28 kg/m2,

6. waist circumference greater than 102 cm for men and greater than 88 cm for women,

7. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Drug:
Olmesartan medoxomil
tablets
Placebo Tablets
Tablets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Incidence of cardiovascular mortality and morbidity Time to occurence No
Secondary Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis) Time to occurrence No
Secondary Occurrence and progression of retinopathy Time to occurence No
Secondary Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease Time to occurrence No
Secondary Safety and tolerability Throughout entire study No
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