NCT00914524

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

June 3, 2009

Last Update Submit

September 28, 2010

Conditions

Chronic GlomerulonephritisDiabetic Nephropathy

Keywords

Chronic GlomerulonephritisDiabetic NephropathyAngiotensin II Receptor BlockerUrinary Protein

Outcome Measures

Primary Outcomes (1)

  • The change in the urinary protein/creatinine ratio from baseline to the end of treatment.

    baseline to 16 weeks

Secondary Outcomes (1)

  • The change of creatinine clearance

    baseline to 16 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: olmesartan medoxomil

Interventions

olmesartan medoxomilDRUG

olmesartan medoxomil tablets, once daily

Treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

October 1, 2006

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations

JP(1)