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Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

NCT ID: NCT00914524

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-10-31

Brief Summary

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The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).

Detailed Description

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Conditions

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Chronic Glomerulonephritis Diabetic Nephropathy

Keywords

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Chronic Glomerulonephritis Diabetic Nephropathy Angiotensin II Receptor Blocker Urinary Protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12.

Group Type EXPERIMENTAL

olmesartan medoxomil

Intervention Type DRUG

olmesartan medoxomil tablets, once daily

Interventions

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olmesartan medoxomil

olmesartan medoxomil tablets, once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
* normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg

Exclusion Criteria

* treatment with corticosteroids or immunosuppressants
* treatment with antihypertensives (other than ARBs and ACE inhibitors)
* serum potassium level of 5.5 mEq/l or above
* serum creatinine level of 2.0 mg/dl or above
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo Co., Ltd.

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CS0866-C-J201

Identifier Type: -

Identifier Source: org_study_id