A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

valsartan

About this trial

This is an interventional treatment trial for Hypertension focused on measuring HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry patients who give written, signed, informed consent. patients with/without mild /moderate hypertension. patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment. patients without any accompanying systemic disease Exclusion Criteria: pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis Other protocol-defined exclusion criteria may apply.

Sites / Locations

Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Change from baseline in urine albumin excretion rate after 24 weeks

Secondary Outcome Measures

Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry

Percent of patients returning to normal urine albumin excretion rate after 24 weeks

Full Information

NCT ID

NCT00171119

First Posted

September 10, 2005

Last Updated

December 16, 2008

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00171119

Brief Title

A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

Official Title

A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Terminated

Study Start Date

January 2004 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Diabetic Nephropathy

Keywords

HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

valsartan

Primary Outcome Measure Information:

Title

Change from baseline in urine albumin excretion rate after 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry

Title

Percent of patients returning to normal urine albumin excretion rate after 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

Inclusion Criteria: male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry patients who give written, signed, informed consent. patients with/without mild /moderate hypertension. patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment. patients without any accompanying systemic disease Exclusion Criteria: pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis Other protocol-defined exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

Basel

Country

Switzerland

Hypertension, Diabetic Nephropathy

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial